ClearanceBrief
Recall Z-0067-2015 ยท FNL Bed, Ac-Powered Adjustable Hospital

Primus Medical LLC

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

DateOct 15, 2014 (initiated Sep 15, 2014)
StatusTerminated
ReasonFirm received several complaints that the head deck actuator bracket had separated from the bed frame.
Root causeDevice Design
ActionPrimus Medical will send a letter notifying all customers with PCB900 beds at their facility of the potential head bracket separation.
Quantity1726
DistributionWorldwide 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.