FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremi…
FUJIFILM Healthcare Americas Corporation · Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
Open FDA's page for this record- Cfres ID
- 207224
- Product res number
- Z-1898-2024
- Event date initiated
- 2024-04-11
- Event date posted
- 2024-05-24
- Recall status
- Open, Classified
- Res event number
- 94443
- Product code
- KPR
- Firm FEI number
- 1000513161
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Address 1
- 81 Hartwell Ave Ste 300 81 Hartwell Ave
- Address 2
- Ste 300
- City
- Lexington
- State
- MA
- Postal code
- 02421-3160
- Additional info contact
- SAME 617-861-5300
- Reason for recall
- Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
- Root cause description
- Component design/selection
- Product quantity
- 18 units
- Distribution pattern
- US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.
- Product description
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33
- Code info
UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002
- Action
FUJIFILM Healthcare Americas Corporation (FUJIFILM) issued Urgent -FIrst Notice letter via email on 4/11/24. Letter states reason for recall, health risk and action to take: 1)Please complete and return the form attached on page 3 of this communication. Providingthe response with the information requested is essential for ensuring appropriate action istaken 2)Please contact Customer Service at 1-888-FUJIMED (1-888-385-4633) to open a serviceticket. 3)Until your upgrade is scheduled and completed, you can continue to safely use FDRVisionary Suite, however, inspect the bolts prior to use. Please contact our field action coordinator, Chaitrali Kulkarni, via email at hcusregulatoryaffairs@fujifilm.com, if you have any further questions regarding this field action.
- K numbers
- K152294
- Harmonized identifiers (openFDA)
- Device name
- System, X-Ray, Stationary
- Medical specialty description
- Radiology
- Regulation number
- 892.1680
- Device class
- 2
- K number
- K102680, K082064, K152788, K904145, K163203, K150506, K883160, K050704, K152767, K223550, K982955, K073632, K934005, K233722, K962896, K940306, K790741, K073114, K122454, K173517, K920347, K231892, K052541, K071430, K111655, K193637, K242119, K220919, K852349, K113855, K191699, K902791, K203340, K981880, K090238, K192541, K080655, K915362, K800788, K050151 +319 more
- Registration number
- 3021059265, 9616014, 3009529630, 3001556265, 3024891354, 9614430, 2126677, 3003202425, 3010300212, 3001722928, 2243057, 3003768251, 3008284470, 3016674851, 8030233, 3013679558, 3016250464, 3013714596, 3029916061, 3006115340, 3009134655, 1450503, 3006051164, 3003768277, 3014209556, 3033525986, 3004977335, 9616047, 3009608361, 3033527770, 3011416394, 3008364043, 3025442726, 1317307, 3027339477, 3005810333, 3030089787, 3006165260, 3012569470, 3035950510 +43 more
- FEI number
- 3021059265, 1000114111, 3002808139, 3009529630, 3001556265, 3024891354, 2126677, 3003202425, 3010300212, 3001722928, 2243057, 3003768251, 3008284470, 3016674851, 3013679558, 3016250464, 3002495042, 3013714596, 3029916061, 3006115340, 3009134655, 1450503, 3006051164, 3003377038, 3014209556, 3033525986, 3004977335, 3009608361, 3033527770, 3011416394, 3008364043, 3025442726, 1317307, 3027339477, 3002175190, 3005810333, 3030089787, 3002143662, 3006165260, 3012569470 +43 more