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U.S. Department of Health and Human Services

Class 2 Device Recall Rehab RAM

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  Class 2 Device Recall Rehab RAM see related information
Date Initiated by Firm November 01, 2011
Date Posted January 25, 2012
Recall Status1 Terminated 3 on August 29, 2013
Recall Number Z-0865-2012
Recall Event ID 60180
Product Classification Wheelchair, mechanical - Product Code IOR
Product Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab RAM

Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.
Code Information Serial number: 35435-0608
Recalling Firm/
Manufacturer		 Gunnell, Inc.
8440 State Rd
Millington MI 48746-9445
For Additional Information Contact Andrew Evancho
989-871-4529
Manufacturer Reason
for Recall		 Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the Rehab Tough and Tilt (TNT), Bariatric Rehab Tough and Tilt (BTNT), Rehab Recline and Mobility (RAM), Bariatric Rehab Recline and Mobility (BRAM), and Rehab Kidster.
FDA Determined
Cause 2		 Component design/selection
Action Gunnell, Inc. sent a Medical Device Correction letters dated November 1, 2011 to all consignees. The letter identified the product, problem, and actions to be taken. The letter states that Gunnell Inc will provide free replacement cylinders and reimburse for each correction verified. The notice instructs customers to complete and return the Response Form. Customers were instructed to notify their customers by including a copy of the correction notice. Question and concerns should be addressed to andy.evancho@gunnell-inc.com. or call 1-800-551-0055, attention Andy Evancho.
Quantity in Commerce 1 unit
Distribution Worldwide Distribution - USA (nationwide) nad the countries of: Australia and 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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