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U.S. Department of Health and Human Services

Class 2 Device Recall PowerPRO 2

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 Class 2 Device Recall PowerPRO 2see related information
Date Initiated by FirmNovember 11, 2022
Date PostedDecember 14, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0479-2023
Recall Event ID 91160
Product Classification Stretcher, wheeled - Product Code FPO
ProductPower-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)
Code Information UDI-DI (GTIN) 07613327504460 Serial Numbers 2204000343 2204000345 2204000348 2204000351 2204000369 2204000370 2204000382 2204000430 2204000673 2204000682 2205000094 2205000095 2205000096 2205000097 2205000098 2205000099 2205000100 2205000101 2205000102 2205000104 2205000105 2205000109 2205000110 2205000111 2205000113 2205000115 2205000117 2205000119 2205000123 2205000124 2205000125 2205000128 2205000129 2205000130 2205000132 2205000135 2205000137 2205000139 2205000142 2205000143 2205000151 2205000170 2208001658 2208001660 2203001748 2204000431 2204000651 2204000663 2204000665 2204000667 2204000670 2204000671 2204000680 2203001948 2203001955 2204000075 2204000094 2204000097 2204000632 2204000633 2204000635 2204000637 2204000647 2204000676 2204000683 2202001579 2202001585 2203002650 2203002651 2203002652 2203002653 2203002654 2203002666 2204000077 2204000078 2204000086 2112001508 2204000681 2204000684 2203001720 2203001925 2203001928 2203001929 2203001932 2203002660 2203002664 2203002665 2204000080 2204000084 2204000089 2204000105 2204000112 2204000675 2202001560 2202001593 2202001594 2203001721 2203001723 2203001744 2203001926 2203001931 2203001945 2203002663 2204000074 2204000076 2204000085 2204000092 2204000109 2204000114 2204000116 2204000117 2204000118 2204000269 2204000271 2204000273 2204000274 2204000275 2204000279 2204000282 2204000283 2204000284 2204000285 2204000286 2204000287 2204000288 2204000289 2204000290 2204000291 2204000292 2204000346 2204000352 2204000381 2204000408 2204000429 2204000433 2204000452 2204000453 2204000636 2204000638 2204000639 2204000640 2204000641 2204000643 2204000645 2204000648 2204000649 2204000652 2204000653 2204000655 2204000656 2204000657 2204000658 2204000662 2205000141 2204000277 2112001535 2204000103 2202001299 2202001314 2202001315 2202001523 2202001539 2202001541 2202001570 2202001572 2202001592 2204000081 2204000098 2204000272 2202000816 2203001944 2203001937 2203001947 2203001934 2203001954 2204000276 2202001580 2204000082 2204000093 2204000646 2204000654 2204000659 2204000661 2204000664 2204000666 2204000677 2204000678 2204000686 2202001535 2202001555 2202001556 2202001565 2202001573 2202001312 2204000294 2204000311 2202000802 2112001492 2203002657 2202001574 2202000811 2112001504 2202001303 2202000797 2202001307 2203001953 2204000293 2202000820 2202000485 2202000478 2112001511 2202000819 2204000309 2112001512 2112001490 2203002658 2202000481 2202000805 2202001300 2202000475 2112001514 2202000824 2202000487 2202000812 2112001526 2202000826 2112001513 2112001521 2203001940 2112001494 2112001529 2202000801 2202001519 2202001309 2112001518 2203002668 2112001520 2112001536 2203001949 2202000480 2112001525 2204000300 2202000807 2202000482 2112001491 2112001496 2112001528 2202001521 2112001517 2204000310 2202000804 2202000477 2202000821 2202001317 2203001956 2202000809 2204000295 2112001485 2204000299 2203002655 2204000099 2202001554 2112001519 2203002659 2202001304 2202000483 2202000803 2202001302 2112001503 2203001930 2202000490 2202001318 2202001308 2112001522 2112001515 2203002667 2202001578 2112001495 2202001316 2112001527 2112001501 2112001534 2112001524 2202000823 2204000304 2202000817 2112001488 2202000800 2112001523 2202001306 2202000476 2202001311 2202000473 2202001301 2112001493 2202000806 2204000308 2204000296 2112001516 2202000479 2112001489 2202000815 2202000474 2202000492 2203002669 2202001313 2112001530 2112001532 2204000302 2202000822 2202001518 2112001533 2204000327 2204000328 2204000329 2204000330 2204000331 2204000332 2112001509 2202000488 2202000489 2202000808 2202000810 2202000813 2203001941 2203001942 2203001943 2203001951 2204000340 2204000634 2204000642 2204000644 2204000650 2203002386 2203002387 2203002388 2203002389 2203002390 2203002391 2203002392 2203002393 2203002394 2203002395 2203002408 2203002409 2203002410 2203002411 2203002412 2203002413 2203002414 2203002415 2203002416 2203002417 2203002418 2208002581 2208002582 2208002583 2208002584 2208002585 2208002586 2208002587 2208002588 2208002589 2208002590 2208002591 2208002592 2208002593 2208002594 2208002595 2208002596 2208002597 2208002598 2208002599 2203002406
FEI Number 1831750
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information ContactVictoria Haney
269-389-8306
Manufacturer Reason
for Recall		Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn November 11, 2022, the firm notified affected customers via "URGENT: MEDICAL DEVICE CORRECTION" letters. Devices require servicing. Customers were instructed to locate affected units and identify the address where they can be serviced. Until servicing can be performed, customers were provided with additional instructions and precautions to follow to ensure safe continued use of the device. Return the enclosed business reply form to confirm receipt of this notification by fax +1 269 488 8691 or email productfieldaction@stryker.com. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the modification/repair of your Power-PRO 2. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. If you have any questions or concerns, contact Customer Service at +1 800 327 0770 Monday through Friday from 8:00 a.m. to 6:00 p.m. ET.
Quantity in Commerce465 (403 US; 62 OUS)
DistributionWorldwide Distribution: US (Nationwide) and Foreign to countries of: Australia, Canada, Netherlands, and United Kingdom.
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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