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Recall Observatory FDA recall evidence

Device product

ProCuity bed series, model number 3009, item number: 3009PX-L-100.

Z-0425-2024

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-0425-2024

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): 07613327541168. Serial numbers: 2111000766 & 2107000368

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.