Recall Z-2248-2012— Stryker Medical Division of Stryker Corporation

Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2012-06-27, terminated 2013-12-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Powered Mobility Offers Versatility (M¿V)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 effort and risk of back injury while transporting a patient up or down a set of stairs. 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 (M¿V) chair was reviewed to identify potential compliance issues in relation to product documentation and classification..

Recalling firm

Stryker Medical Division of Stryker Corporation

Classification

Class II

Status

Terminated

Initiated

2012-06-27

Terminated

2013-12-30

Firm location

Portage, MI, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.