Z-0067-2015 Class II Terminated
FDA device recall Z-0067-2015 was initiated by Primus Medical LLC on September 15, 2014 and is designated Class II. Reason for recall: Firm received several complaints that the head deck actuator bracket had separated from the bed frame. The recall status is terminated (terminated August 10, 2017). Affected quantity: 1726.
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2014
- Initiation Date
- September 15, 2014
- Termination Date
- August 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1726
Product Description
AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities.
Reason for Recall
Firm received several complaints that the head deck actuator bracket had separated from the bed frame.
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.
Code Information
PCB900 manufactured between 09/13/2010 and 05/22/2012