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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0067-2015 | Class II | Terminated | Voluntary: Firm initiated |
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