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U.S. Department of Health and Human Services

Class 2 Device Recall Prime Care Bed PCB900

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  Class 2 Device Recall Prime Care Bed PCB900 see related information
Date Initiated by Firm September 15, 2014
Date Posted October 15, 2014
Recall Status1 Terminated 3 on August 10, 2017
Recall Number Z-0067-2015
Recall Event ID 69357
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product AC Powered adjustable bed frame.

AC powered adjustable bed frame used in nursing facilities.
Code Information PCB900 manufactured between 09/13/2010 and 05/22/2012
Recalling Firm/
Manufacturer		 Primus Medical LLC
8401 Southern Blvd
Boardman OH 44512-6709
Manufacturer Reason
for Recall		 Firm received several complaints that the head deck actuator bracket had separated from the bed frame.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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