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ProCuity recallZ-0436-2024 · Stryker Medical Division of Stryker Corporation · initiated Aug 30, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Medical Division of Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

FDA root cause category: Process control

What the company is doing

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 [email protected]. 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.

Recall details

Recall number
Z-0436-2024
Status
Open, Classified
Initiated by the company
Aug 30, 2023
Posted by the FDA
Dec 1, 2023
Recalling firm
Stryker Medical Division of Stryker Corporation
Product code
FNL
Distribution
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

Product description

ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.

Code information (models, lots, serial numbers)

UDI-DI (GTIN): 07613327541366. Serial numbers: 2105004433, 2105004422, 2110001418, 2110001260, 2110000511, & 2110000496

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 93317).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page