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U.S. Department of Health and Human Services

Class 2 Device Recall Invacare Homecare Series Bed and Invacare GSeries Beds

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 Class 2 Device Recall Invacare Homecare Series Bed and Invacare GSeries Bedssee related information
Date Initiated by FirmJanuary 22, 2024
Date PostedMarch 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1251-2024
Recall Event ID 93875
Product Classification Bed, therapeutic, ac-powered, adjustable home-use - Product Code LLI
ProductInvacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW
Code Information (1) G50 HEAD SECTION FULL ELECTRIC G-SERIES BED Serial Number 23HX000383 23HX000384 23HX000385 23HX000386 23HX000387 23HX000388 23HX000389 23HX000390 23HX000391 23HX000392 23HX000396 23HX000406 23HX000407 23HX000408 23HX000409 23HX000410 23HX000411 23HX000412 23HX000413 23HX000414 23HX000421 23HX000437 23HX000438 23HX000453 23HX000454 23HX000456 23HX000457 23HX000458 23HX000459 23HX000460 23HX000461 23HX000462 23HX000463 23HX000464 23HX000470 23HX000471 23HX000474 23HX000475 23HX000476 23HX000477 23HX000478 23HX000479 23HX000480 23HX000481 23HX000482 23HX000483 23HX000484 23HX000485 23HX000486 23HX000487 23HX000488 23HX000489 23HX000490 23HX000491 23HX000492 23HX000493 23HX000494 23HX000495 23HX000496 23HX000497 23HX000498 23HX000499 23HX000500 23HX000501 23HX000502 23HX000503 23HX000504 23HX000505 23HX000506 23HX000507 23HX000513 23HX000514 23HX000515 23HX000521 23HX000522 23HX000524 23HX000530 23HX000531 23HX000534 23HX000535 23HX000536 23HX000537 23HX000538 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Recalling Firm/
Manufacturer		 Invacare Corporation
1 Invacare Way
Elyria OH 44035-4190
For Additional Information ContactRecall Support Line: (877)
877-413-6008
Manufacturer Reason
for Recall		Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components
FDA Determined
Cause 2		Process design
ActionInvacare issued Urgent Medical Device Correction letter on 12/22/23. Letter states reason for recall, health risk and action to take: 1.Please locate your affected products Please review your records to locate the affected components. Above is a list of model numbers to assist you with this process. 2. Please contact your provider at the number listed below to have the bed component replaced.
Quantity in Commerce8,117 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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