Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0067-2015Class II

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

Primus Medical LLC / initiated 2014-09-15 / Terminated / root cause: design

Primus Medical LLC began a recall of AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities on . FDA classified it as Class II and gives the reason as "Firm received several complaints that the head deck actuator bracket had separated from the bed frame". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0067-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Primus Medical LLC
Product
AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
Firm received several complaints that the head deck actuator bracket had separated from the bed frame.
Root cause tag
design
FDA root cause
Device Design
Action
Primus Medical will send a letter notifying all customers with PCB900 beds at their facility of the potential head bracket separation.
Quantity in commerce
1726
Distribution
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.
Product codes and lots
PCB900 manufactured between 09/13/2010 and 05/22/2012

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0067-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0067-2015Class IITerminatedVoluntary: Firm initiated