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U.S. Department of Health and Human Services

Class 2 Device Recall ProCuity

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  Class 2 Device Recall ProCuity see related information
Date Initiated by Firm August 30, 2023
Date Posted December 01, 2023
Recall Status1 Open3, Classified
Recall Number Z-0428-2024
Recall Event ID 93317
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
Code Information UDI-DI (GTIN): 07613327541175. Serial numbers: 2109000993 , 2208000147 , 2209000850 , 2211002051 , 2202000910 , 2209000408 , 2205000619 , 2205000615 , 2205000612 , 2205000587 , 2205000746 , 2205000745 , 2205000739 , 2109000135 , 2109000124
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information Contact Victoria Haney
269-389-8306
Manufacturer Reason
for Recall		 Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
FDA Determined
Cause 2		 Process control
Action A customer notification was sent October 20, 2023 via FedEx. Users are to (1) Locate affected units and identify the address where they can be serviced. (2) Return the business reply form by fax +1 269 488-8691 or email to productfieldaction@stryker.com. Upon receipt of the completed business reply form, Stryker will contact you to arrange a time to complete the required electrical tests. (3) Forward notification to any new user/location and advise Stryker of the new address or device status if disposed of or obsolete using the reply form. Address questions or concerns to Customer Service at +1 800 327-0770 Monday through Friday from 8:00 a.m. to 6:00 p.m. ET.
Distribution Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
Total Product Life Cycle TPLC 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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