Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Loss of connectivity between the FlexArm and the Table due to a software issue.
Open FDA's page for this record- Cfres ID
- 205317
- Product res number
- Z-0860-2024
- Event date initiated
- 2023-12-08
- Event date posted
- 2024-01-30
- Recall status
- Open, Classified
- Res event number
- 93721
- Product code
- OWB
- Product description
- Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
- Firm FEI number
- 3002807880
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Address 1
- Veenpluis 4-6 4-6 veenpluis
- City
- Best
- Country
- Netherlands
- Reason for recall
- Loss of connectivity between the FlexArm and the Table due to a software issue.
- Root cause description
- Under Investigation by firm
- Product quantity
- 28 systems (9 US, 1 Canada, 18 ROW)
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.
- Code info
(1) System Code: 722079; (1) UDI/DI: 00884838085268; (1) Serial Number: 1086, 1392, 703615, 1079, 743, 703456, 1248; (2) System Code: 722224; (2) UDI/DI: 00884838099258; (2) Serial Number: 1337, 1249, 1925, 1250, 468, 379, 647, 633, 1534, 887, 1349, 280, 969, 197, 1177, 455, 3, 2611, 2716, 606, 2025;
- Action
The recalling firm issued an URGENT: MEDICAL DEVICE CORRECTION notification dated 12/08/2023 by certified mail to consignees. Consignees with affected devices are asked to utilize the provided workaround instructions. Additionally, consignees are asked to make all users aware of this recall notification and keep a copy of this notification with system documentation. Getinge Field Service Engineers will be dispatched to the field to install software updates to affected devices. Consignees with any questions can contact the recalling firm by phone at 1-800-722-9377. Consignees are asked to return the provided response form to the recalling firm at ITG_Recalls@philips.com.
- K numbers
- K200917
- Harmonized identifiers (openFDA)
- Device name
- Interventional Fluoroscopic X-Ray System
- Medical specialty description
- Radiology
- Regulation number
- 892.1650
- Device class
- 2
- K number
- K243735, K170130, K253670, K221344, K220342, K173631, K180473, K243884, K211191, K200917, K050489, K211780, K212442, K231700, K101868, K181550, K173314, K251523, K163715, K123508, K181804, K240465, K032046, K231669, K130638, K172646, K062647, K203281, K052202, K181834, K002198, K212383, K033244, K230787, K160147, K961374, K123529, K181415, K222625, K233230 +285 more
- Registration number
- 3021059265, 3016438694, 3014391847, 2027467, 3038614464, 3010398867, 9681146, 3004785967, 3015223550, 3009196578, 3008632256, 3003202425, 3012761544, 1723170, 3001722928, 2243057, 3003768251, 3021561977, 3010703925, 3036666444, 3021027284, 3013184485, 3022378058, 3008284470, 3011713200, 3027373189, 3036255956, 3018094310, 8030233, 3006544299, 3016248538, 1225677, 3009973505, 1037955, 2133772, 3008363989, 3025394757, 2939520, 3030412764, 3014343100 +86 more
- FEI number
- 3021059265, 3016438694, 1000114111, 3014391847, 2027467, 3038614464, 3002808139, 3010398867, 3004785967, 3015223550, 3009196578, 3008632256, 3003202425, 3012761544, 3001722928, 2243057, 3002980729, 3003768251, 3021561977, 3010703925, 3036666444, 3021027284, 3013184485, 3022378058, 3008284470, 3011713200, 3027373189, 3036255956, 3018094310, 3006544299, 3016248538, 3009973505, 1037955, 1000132370, 3008363989, 3025394757, 2939520, 3030412764, 3014343100, 1000188474 +86 more