Device recalls

Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascula…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Potential for pressure wave data synchronization from two devices may not be correct.

Open, ClassifiedComponent design/selectionZ-1926-2024
Open FDA's page for this record
Cfres ID
207659
Product res number
Z-1926-2024
Event date initiated
2024-05-02
Event date posted
2024-05-30
Recall status
Open, Classified
Res event number
94593
Product code
MWI
Product description
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
Firm FEI number
3002807880
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Address 1
Veenpluis 4-6 4-6 veenpluis
City
Best
Country
Netherlands
Additional info contact
Virginia Huete 615-679227 Ext. 31
Reason for recall
Potential for pressure wave data synchronization from two devices may not be correct.
Root cause description
Component design/selection
Product quantity
391 units
Code info

Software Versions 1.2.0, 1.2.1, 1.2.2, 1.2.3, 1.3.0, 1.3.1. Model No. 722467; UDI: (01)00884838100084 (11)200826(10)5.2.0.0, (01)00884838101180(21)616, (01)00884838101180(21)349, (01)00884838101180(21)2111600488, (01)00884838101180(21)2111601116, (01)00884838101180(21)482, (01)00884838101180(21)412, (01)00884838101180(21)2111601659, (01)00884838101180(21)2111601041, (01)00884838101180(21)2111601582, (01)00884838101180(21)251, (01)00884838101180(21)934, (01)00884838101180(21)305, (01)00884838101180(21)295, (01)00884838101180(21)2111600498, (01)00884838101180(21)217, (01)00884838101180(21)527, (01)00884838101180(21)2111600927, (01)00884838101180(21)247, (01)00884838101180(21)431, (01)00884838101180(21)2111601322, (01)00884838101180(21)2111600711, (01)00884838101180(21)455, (01)00884838101180(21)256, (01)00884838101180(21)268, (01)00884838101180(21)744, (01)00884838101180(21)795, (01)00884838101180(21)800, (01)00884838101180(21)64, (01)00884838101180(21)2111601489, (01)00884838101180(21)685, (01)00884838101180(21)2111600884, (01)00884838101180(21)2111600887, (01)00884838101180(21)629, (01)00884838101180(21)2111600641, (01)00884838101180(21)2111601079, (01)00884838101180(21)2111601443, (01)00884838101180(21)2111601444, (01)00884838101180(21)1104, (01)00884838101180(21)1133, (01)00884838101180(21)812, (01)00884838101180(21)2111601067, (01)00884838101180(21)571, (01)00884838101180(21)2111600465, (01)00884838101180(21)2111600628, (01)00884838101180(21)2111600809, (01)00884838101180(21)1195, (01)00884838101180(21)2111601172, (01)00884838101180(21)2111601176, (01)00884838101180(21)168, (01)00884838101180(21)2111600797, (01)00884838101180(21)2111600664, (01)00884838101180(21)195, (01)00884838101180(21)196, (01)00884838101180(21)780, (01)00884838101180(21)781, (01)00884838101180(21)69, (01)00884838101180(21)2111600764, (01)00884838101180(21)2111601312, (01)00884838101180(21)2111600814, (01)00884838101180(21)42, (01)00884838101180(21)129, (01)00884838101180(21)130, (01)00884838101180(21)2111600936, (01)00884838101180(21)2111600794, (01)00884838101180(21)105, (01)00884838101180(21)2111601478, (01)00884838101180(21)2111600759, (01)00884838101180(21)2111601677, (01)00884838101180(21)2111601338, (01)00884838101180(21)496, (01)00884838101180(21)1155, (01)00884838101180(21)1156, (01)00884838101180(21)2111601612, (01)00884838101180(21)2111601613, (01)00884838101180(21)65, (01)00884838101180(21)62, (01)00884838101180(21)2111601229, (01)00884838101180(21)480, (01)00884838101180(21)983, (01)00884838101180(21)206, (01)00884838101180(21)1151, (01)00884838101180(21)2111600934, (01)00884838101180(21)187, (01)00884838101180(21)2111601628, (01)00884838101180(21)448, (01)00884838101180(21)831, (01)00884838101180(21)832, (01)00884838101180(21)833, (01)00884838101180(21)2111601039, (01)00884838101180(21)970, (01)00884838101180(21)971, (01)00884838101180(21)972, (01)00884838101180(21)973, (01)00884838101180(21)2111601409, (01)00884838101180(21)2111601464, (01)00884838101180(21)2111601357, (01)00884838101180(21)1126, (01)00884838101180(21)357, (01)00884838101180(21)48, (01)00884838101180(21)2111600567, (01)00884838101180(21)2111601040, (01)00884838101180(21)953, (01)00884838101180(21)87, (01)00884838101180(21)259, (01)00884838101180(21)2111600694, (01)00884838101180(21)2111600791, (01)00884838101180(21)2111600924, (01)00884838101180(21)681, (01)00884838101180(21)694, (01)00884838101180(21)24, (01)00884838101180(21)25, (01)00884838101180(21)1088, (01)00884838101180(21)1173, (01)00884838101180(21)2111601091, (01)00884838101180(21)2111600656, (01)00884838101180(21)2111600568, (01)00884838101180(21)2111600578, (01)00884838101180(21)2111600817, (01)00884838101180(21)2111600778, (01)00884838101180(21)324, (01)00884838101180(21)535, (01)00884838101180(21)2111600769, (01)00884838101180(21)2111601672, (01)00884838101180(21)1135, (01)00884838101180(21)2111600433, (01)00884838101180(21)646, (01)00884838101180(21)1140, (01)00884838101180(21)2111601431, (01)00884838101180(21)2111601436, (01)00884838101180(21)2111601437, (01)00884838101180(21)2111601438, (01)00884838101180(21)2111601439, (01)00884838101180(21)889, (01)00884838101180(21)101, (01)00884838101180(21)608, (01)00884838101180(21)609, (01)00884838101180(21)892, (01)00884838101180(21)565, (01)00884838101180(21)821, (01)00884838101180(21)759, (01)00884838101180(21)335, (01)00884838101180(21)1167, (01)00884838101180(21)2111600468, (01)00884838101180(21)7, (01)00884838101180(21)1032, (01)00884838101180(21)1033, (01)00884838101180(21)1160, (01)00884838101180(21)2111601675, (01)00884838101180(21)2111601701, (01)00884838101180(21)2111601702, (01)00884838101180(21)590, (01)00884838101180(21)986, (01)00884838101180(21)987, (01)00884838101180(21)988, (01)00884838101180(21)989, (01)00884838101180(21)990, (01)00884838101180(21)1040, (01)00884838101180(21)2111601143, (01)00884838101180(21)2111601273, (01)00884838101180(21)395, (01)00884838101180(21)2111600551, (01)00884838101180(21)2111600611, (01)00884838101180(21)2111601493, (01)00884838101180(21)2111601494, (01)00884838101180(21)2111601495, (01)00884838101180(21)2111600613, (01)00884838101180(21)2111601221, (01)00884838101180(21)643, (01)00884838101180(21)2111601370, (01)00884838101180(21)729, (01)00884838101180(21)730, (01)00884838101180(21)731, (01)00884838101180(21)2111600635, (01)00884838101180(21)1137, (01)00884838101180(21)1015, (01)00884838101180(21)123, (01)00884838101180(21)124, (01)00884838101180(21)125, (01)00884838101180(21)2111600955, (01)00884838101180(21)2111600956, (01)00884838101180(21)433, (01)00884838101180(21)1106, (01)00884838101180(21)204, (01)00884838101180(21)834, (01)00884838101180(21)2111600684, (01)00884838101180(21)873, (01)00884838101180(21)998, (01)00884838101180(21)2111601213, (01)00884838101180(21)2111601255, (01)00884838101180(21)2111601332, (01)00884838101180(21)2111601323, (01)00884838101180(21)2111601204, (01)00884838101180(21)203, (01)00884838101180(21)2111601706, (01)00884838101180(21)2111601707, (01)00884838101180(21)2, (01)00884838101180(21)3, (01)00884838101180(21)2111601327, (01)00884838101180(21)2111601681, (01)00884838101180(21)262, (01)00884838101180(21)57, (01)00884838101180(21)2111601175, (01)00884838101180(21)150, (01)00884838101180(21)151, (01)00884838101180(21)152, (01)00884838101180(21)138, (01)00884838101180(21)139, (01)00884838101180(21)145, (01)00884838101180(21)156, (01)00884838101180(21)300, (01)00884838101180(21)980, (01)00884838101180(21)2111600495, (01)00884838101180(21)2111601220, (01)00884838101180(21)2111601154, (01)00884838101180(21)2111601798, (01)00884838101180(21)613, (01)00884838101180(21)614, (01)00884838101180(21)2111600763, (01)00884838101180(21)2111601165, (01)00884838101180(21)2111601235, (01)00884838101180(21)283, (01)00884838101180(21)539, (01)00884838101180(21)2111601002, (01)00884838101180(21)182, (01)00884838101180(21)337, (01)00884838101180(21)343, (01)00884838101180(21)344, (01)00884838101180(21)345, (01)00884838101180(21)620, (01)00884838101180(21)2111600445, (01)00884838101180(21)1161, (01)00884838101180(21)86, (01)00884838101180(21)282, (01)00884838101180(21)2111600777, (01)00884838101180(21)2111601725, (01)00884838101180(21)2111601726, (01)00884838101180(21)2111601727, (01)00884838101180(21)2111601728, (01)00884838101180(21)2111600583, (01)00884838101180(21)2111600588, (01)00884838101180(21)2111600589, (01)00884838101180(21)2111600590, (01)00884838101180(21)2111600564, (01)00884838101180(21)655, (01)00884838101180(21)656, (01)00884838101180(21)2111600970, (01)00884838101180(21)132, (01)00884838101180(21)2111601321, (01)00884838101180(21)814, (01)00884838101180(21)575, (01)00884838101180(21)611, (01)00884838101180(21)169, (01)00884838101180(21)191, (01)00884838101180(21)212, (01)00884838101180(21)2111601103, (01)00884838101180(21)2111601104, (01)00884838101180(21)146, (01)00884838101180(21)2111601584, (01)00884838101180(21)948, (01)00884838101180(21)2111601253, (01)00884838101180(21)1147, (01)00884838101180(21)490, (01)00884838101180(21)2111600614, (01)00884838101180(21)2111601550, (01)00884838101180(21)207, (01)00884838101180(21)1141, (01)00884838101180(21)157, (01)00884838101180(21)598, (01)00884838101180(21)2111601248, (01)00884838101180(21)2111600451, (01)00884838101180(21)192, (01)00884838101180(21)188, (01)00884838101180(21)189, (01)00884838101180(21)190, (01)00884838101180(21)2111600692, (01)00884838101180(21)2111600963, (01)00884838101180(21)2111600964, (01)00884838101180(21)2111600965, (01)00884838101180(21)2111600966, (01)00884838101180(21)763, (01)00884838101180(21)776, (01)00884838101180(21)263, (01)00884838101180(21)1020, (01)00884838101180(21)1021, (01)00884838101180(21)1022, (01)00884838101180(21)841, (01)00884838101180(21)2111600651, (01)00884838101180(21)310, (01)00884838101180(21)311, (01)00884838101180(21)2111600824, (01)00884838101180(21)2111600825, (01)00884838101180(21)278, (01)00884838101180(21)373, (01)00884838101180(21)2111600693, (01)00884838101180(21)93, (01)00884838101180(21)612, (01)00884838101180(21)11, (01)00884838101180(21)186, (01)00884838101180(21)793, (01)00884838101180(21)706, (01)00884838101180(21)2111600659, (01)00884838101180(21)2111600660, (01)00884838101180(21)653, (01)00884838101180(21)961, (01)00884838101180(21)2111601446, (01)00884838101180(21)898, (01)00884838101180(21)665, (01)00884838101180(21)2111600627, (01)00884838101180(21)2111600463, (01)00884838101180(21)662, (01)00884838101180(21)1086, (01)00884838101180(21)1162, (01)00884838101180(21)2111600541, (01)00884838101180(21)2111600479, (01)00884838101180(21)2111600480, (01)00884838101180(21)2111601720, (01)00884838101180(21)530, (01)00884838101180(21)607, (01)00884838101180(21)339, (01)00884838101180(21)2111601054, (01)00884838101180(21)119, (01)00884838101180(21)120, (01)00884838101180(21)2111600658, (01)00884838101180(21)756, 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(01)00884838101180(21)83, (01)00884838101180(21)78, (01)00884838101180(21)2111600545, (01)00884838101180(21)2111600554, (01)00884838101180(21)2111601249, (01)00884838101180(21)1007, (01)00884838101180(21)2111601688; Serial No: CZC9509HWC, CZC950919K, CZC9509HTZ, CZC112CW4W, 3203, 616, MXL2342FBK, MXL2342F9N, MXL2342F9D, MXL221294Q, MXL221294Z, CZC12095LJ, CZC12175YY, MXL221293R, MXL221293Y, MXL2342F16, MXL2342FOC, MXL2342FB4, MXL2342FB9, MXL2342F9K, CZC1088DDM, CZC1099NF4, MXL3362KYB, CZC1077045, CZC107704M, CZC1077043, CZC107705D, 349, 2111600488, 2111601116, 482, 412, 2111601659, 2111601041, 2111601582, 251, 934, 305, 295, 2111600498, 217, 527, 2111600927, 247, 431, 2111601322, 2111600711, 455, 256, 268, 744, 795, 800, 64, 2111601489, 685, 2111600884, 2111600887, 629, 2111600641, 2111601079, 2111601443, 2111601444, 1104, 1133, 812, 2111601067, 571, 2111600465, 2111600628, 2111600809, 1195, 2111601172, 2111601176, 168, 2111600797, 2111600664, 195, 196, 780, 781, 69, 2111600764, 2111601312, 2111600814, 42, 129, 130, 2111600936, 2111600794, 105, 2111601478, 2111600759, 2111601677, 2111601338, 496, 1155, 1156, 2111601612, 2111601613, 65, 62, 2111601229, 480, 983, 206, 1151, 2111600934, 187, 2111601628, 448, 831, 832, 833, 2111601039, 970, 971, 972, 973, 2111601409, 2111601464, 2111601357, 1126, 357, 48, 2111600567, 2111601040, 953, 87, 259, 2111600694, 2111600791, 2111600924, 681, 694, 24, 25, 1088, 1173, 2111601091, 2111600656, 2111600568, 2111600578, 2111600817, 2111600778, 324, 535, 2111600769, 2111601672, 1135, 2111600433, 646, 1140, 2111601431, 2111601436, 2111601437, 2111601438, 2111601439, 889, 101, 608, 609, 892, 565, 821, 759, 335, 1167, 2111600468, 7, 1032, 1033, 1160, 2111601675, 2111601701, 2111601702, 590, 986, 987, 988, 989, 990, 1040, 2111601143, 2111601273, 395, 2111600551, 2111600611, 2111601493, 2111601494, 2111601495, 2111600613, 2111601221, 643, 2111601370, 729, 730, 731, 2111600635, 1137, 1015, 123, 124, 125, 2111600955, 2111600956, 433, 1106, 204, 834, 2111600684, 873, 998, 2111601213, 2111601255, 2111601332, 2111601323, 2111601204, 203, 2111601706, 2111601707, 2, 3, 2111601327, 2111601681, 262, 57, 2111601175, 150, 151, 152, 138, 139, 145, 156, 300, 980, 2111600495, 2111601220, 2111601154, 2111601798, 613, 614, 2111600763, 2111601165, 2111601235, 283, 539, 2111601002, 182, 337, 343, 344, 345, 620, 2111600445, 1161, 86, 282, 2111600777, 2111601725, 2111601726, 2111601727, 2111601728, 2111600583, 2111600588, 2111600589, 2111600590, 2111600564, 655, 656, 2111600970, 132, 2111601321, 814, 575, 611, 169, 191, 212, 2111601103, 2111601104, 146, 2111601584, 948, 2111601253, 1147, 490, 2111600614, 2111601550, 207, 1141, 157, 598, 2111601248, 2111600451, 192, 188, 189, 190, 2111600692, 2111600963, 2111600964, 2111600965, 2111600966, 763, 776, 263, 1020, 1021, 1022, 841, 2111600651, 310, 311, 2111600824, 2111600825, 278, 373, 2111600693, 93, 612, 11, 186, 793, 706, 2111600659, 2111600660, 653, 961, 2111601446, 898, 665, 2111600627, 2111600463, 662, 1086, 1162, 2111600541, 2111600479, 2111600480, 2111601720, 530, 607, 339, 2111601054, 119, 120, 2111600658, 756, 2111600992, 720, 633, 725, 377, 384, 2111600602, 2111600668, 2111601652, 2111600560, 2111600846, 599, 491, 288, 950, 606, 143, 667, 135, 1039, 82, 2111600525, 2111600530, 2111601250, 159, 2111600499, 468, 2111601547, 658, 2111601319, 1037 600, 1197, 83, 78, 2111600545, 2111600554, 2111601249, 1007, 2111601688.

Action

Consignees were mailed an URGENT Medical Device Correction notice, dated 4/30/24. Consignees are instructed to keep the provided notification with the documentation of affected systems until Philips implements the software correction, follow the provided instructions when connecting the pressure wire to the FM-PIM and refer to the FM Patient Interface Module (Option Manual, Chapters 3 and 5), and circulate the provided notification to all users of the system. In the case that steps described in the notification are not executed and/or the described issue is observed, perform the normalization procedure in accordance with Section 6.9 of the IFU for the Philips Hemodynamic Application. Consignees are to complete and return the provided response form within 30 days of receipt. Customers with any questions are to contact Philips Customer Care Solutions Center at 1-800-722-9377. Philips will install a software update to correct this issue and will contact consignees to schedule the onsite visit to perform the upgrade.

Distribution pattern

Worldwide distribution - US Nationwide in the states of CA, IN, OR and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, Costa Rica, C¿te D'Ivoire, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hungary, India, Ireland, Italy, Malaysia, Martinique, Netherlands, New Zealand, Oman, Pakistan, Panama, Poland, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Thailand, Ukraine, United Kingdom.

K numbers
K181311
Harmonized identifiers (openFDA)
Device name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Medical specialty description
Cardiovascular
Regulation number
870.2300
Device class
2
K number
K142087, K983928, K210204, K010732, K082564, K200160, K202892, K130056, K191059, K212161, K112877, K182900, K041918, K130796, K133810, K012059, K051518, K002967, K101445, K031863, K060756, K171361, K000404, K172959, K061590, K071802, K001020, K033988, K260801, K241411, K170168, K023195, K060712, K093177, K051897, K131786, K041942, K100424, K170032, K003622 +270 more
Registration number
3047896295, 8030229, 3024491912, 3016931915, 3009673645, 3003832357, 3008283443, 3010392999, 3013596024, 3004145393, 1064859, 8040564, 3011353843, 3013501110, 2520313, 3022425463, 3007615597, 3031563234, 9681548, 3037341611, 3000976525, 3012494290, 3032013079, 3008164770, 3010041430, 3038259592, 1058584, 3005439460, 3004091281, 3010390468, 3001570235, 3007137598, 3005569927, 3014886121, 3011359729, 3021343210, 3007134734, 3016852448, 3016670256, 8021084 +136 more
FEI number
3047896295, 3024491912, 1000114111, 3016931915, 3002897588, 3009673645, 3003832357, 3008283443, 3010392999, 3013596024, 3004145393, 3011353843, 3013501110, 2520313, 3022425463, 1000292048, 6736, 1000271197, 3007615597, 3031563234, 3037341611, 3000976525, 3012494290, 3032013079, 3008164770, 3010041430, 3002806783, 3038259592, 3005439460, 3010390468, 3001570235, 3007137598, 3005569927, 3014886121, 3011359729, 3021343210, 3007134734, 3007513035, 3016852448, 3016670256 +136 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.