Recall Z-0435-2024 ยท FNL Bed, Ac-Powered Adjustable Hospital
Stryker Medical Division of Stryker Corporation
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
| Date | Dec 1, 2023 (initiated Aug 30, 2023) |
| Status | Open, Classified |
| Reason | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. |
| Root cause | 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 |
| Distribution | Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.