Skip to content
Recall Observatory FDA recall evidence

Device product

ProCuity bed series, model number 3009, item number: 3009PX-LE-400.

Z-0427-2024

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-0427-2024

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): 07613327541182. Serial numbers: 2105002838 , 2105002832 , 2202000312 , 2202000286 , 2202000278 , 2202000180 , 2106002241 , 2106001240 , 2107001002 , 2203001053 , 2203001898 , 2112001135 , 2211002054 , 2105002782 , 2210002902 , 2210002890 , 2210002876 , 2210002858 , 2210002848 , 2111001420 , 2206001182

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.