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Recall Observatory FDA recall evidence

Device product

Handicare P600 Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.

Z-2753-2018

November 03, 2017

Class II

Product summary

Firm
Handicare Usa Inc
Event
Event 80556
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-2753-2018

Official wording

Reason: Premature strap wear and breakage at maximum weight conditions (625 lbs.).

Code information: Device Model; 303090 and 303093

Distribution pattern: Worldwide Distribution - US Nationwide in the states of AK, CA, CT, DE, GA, IA, IL, KY, LA, MA, ME, MI, MN, MO, NE, NV, NY, OH, OR, PA, RI, TN, TX, WI, and Puerto Rico and the countries of Canada and Australia,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Premature strap wear and breakage at maximum weight conditions (625 lbs.).