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Recall Observatory FDA recall evidence

Device product

Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001

Z-1256-2023

February 01, 2023

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 91716
Status
Ongoing
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-1256-2023

Official wording

Reason: Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport.

Code information: GTIN: 07613327559118 Serial Numbers: 2208002066, 2208002071, 2209001508, 2208001664

Distribution pattern: US Nationwide distribution in the states of NY, VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport.