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Recall Observatory FDA recall evidence

Device product

AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities.

Z-0067-2015

September 15, 2014

Class II

Product summary

Firm
Primus Medical LLC
Event
Event 69357
Status
Terminated
Classification
Class II
Quantity
1726
Official record key
device-enforcement:Z-0067-2015

Official wording

Reason: Firm received several complaints that the head deck actuator bracket had separated from the bed frame.

Code information: PCB900 manufactured between 09/13/2010 and 05/22/2012

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of CA, DE, FL, GA, IL, IN, KS, KY, MA, MN,MS, NC, NM, NV, NY, OH, PA, TN, TX, and VA, and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm received several complaints that the head deck actuator bracket had separated from the bed frame.