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U.S. Department of Health and Human Services

Class 2 Device Recall CSeries Carry Bar

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  Class 2 Device Recall CSeries Carry Bar see related information
Date Initiated by Firm January 27, 2013
Date Posted June 21, 2013
Recall Status1 Open3, Classified
Recall Number Z-1578-2013
Recall Event ID 65193
Product Classification Lift, patient, ac-powered - Product Code FNG
Product Prism Medical C-Series Carry Bar, Class I, model number 360755.

The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.
Code Information model number 360755
Recalling Firm/
Prism Medical Services USA
45 Progress Pkwy
Maryland Heights MO 63043-3701
For Additional Information Contact Agustin Garcia de Paredes, P. Eng
905-850-9003 Ext. 249
Manufacturer Reason
for Recall
The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars.
FDA Determined
Cause 2
Use error
Action The firm, Prism Medical, sent a letter dated January 27, 2013 to is customers.The letter described the product, problem and actions to be taken. The customers were instructed to perform an immediate safety check checking that both the pin and the plug have been inserted into the carry bar as outlined in the attached User Instruction guide. Prism offered to replace the recalled product with a different product with greater functionality. If you have any questions, contact VP-Global Product Development at 416-726-3107.
Quantity in Commerce 1131 carry bars/New England
Distribution Worldwide distribution: US (nationwide) and 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.