Recall Z-0867-2012 ยท IOR Wheelchair, Mechanical
Gunnell, Inc.
Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab MAC Platform Chair 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.
| Date | Jan 25, 2012 (initiated Nov 1, 2011) |
| Status | Terminated |
| Reason | Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs with dynamic recline would not hold a firm position, or as described by users, the back support or canes were spongy. |
| Root cause | 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 | 7 units |
| Distribution | Worldwide Distribution - USA (nationwide) nad the countries of: Australia and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.