Recall Z-2247-2012 ยท ILK Transport, Patient, Powered
Stryker Medical Division of Stryker Corporation
Powered Mobility Offers Versatility (MV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator
| Date | Aug 22, 2012 (initiated Jun 27, 2012) |
| Status | Terminated |
| Reason | Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification. |
| Root cause | PMA |
| Action | Stryker sent a Urgent Medical Device Recall notice dated June 18, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to " Return the enclosed post card to confirm receipt of this notification. " Locate the chairs listed in this notice. " Call 269-389-6750 to arrange shipment of the chairs to Stryker Medical. " If you have loaned or sold any of the chairs listed in this letter, please, forward a copy of this notice to the new users and advise us of their new location. " If you have dispo |
| Quantity | 159 units |
| Distribution | Worldwide Distribution -- USA (nationwide) including the states of AK, AL, AZ, CA, FL, ID, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OR, PA, TN, TX, UT, UT, VA, WA, WI, and WV, and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.