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Recall Observatory FDA recall evidence

Device product

ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.

Z-0430-2024

August 30, 2023

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 93317
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0430-2024

Official wording

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

Code information: UDI-DI (GTIN): 07613327541236. Serial numbers: 2207000806 , 2101001244 , 2206000635 , 2206000628 , 2206000626 , 2206000483 , 2206000479 , 2206000412 , 2206000405 , 2206000401 , 2206000177 , 2205000560 , 2107001062 , 2107001046 , 2205000843 , 2205000841 , 2205000840 , 2205000836 , 2205000832 , 2208000197 , 2208000174 , 2208000156 , 2211002859 , 2205000935 , 2207001318 , 2207001289 , 2207001178 , 2207001163 , 2207001155 , 2207001114 , 2211000184 , 2211000209 , 2207001100 , 2207001097 , 2207001095 , 2207001600 , 2207001071 , 2207001037 , 2207001028 , 2204000753 , 2204000750 , 2204000542 , 2204000195 , 2203002255 , 2203002137 , 2203002129 , 2203001533 , 2203001527 , 2203001424 , 2203001163 , 2203000232 , 2203000230 , 2203000208 , 2203000044 , 2203000036 , 2203000033 , 2107001094 , 2203000005 , 2202001013 , 2202000678 , 2202000506 , 2104002546 , 2104002532 , 2104002512 , 2104002501 , 2104001704 , 2105005200 , 2103001843 , 2103001783 , 2102000290 , 2210003278 , 2208000758 , 2109002018 , 2011000511 , 2011000497 , 2202000089 , 2211004212 , 2109002745

Distribution pattern: Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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