Powered Mobility Offers Versatility (MV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair

FDA device recall Z-2247-2012 · posted 2012-08-22 · Terminated

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

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.

Action taken

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 disposed of any of the affected chairs and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. We apologize for any disruption that this advisory notice may cause. We strive to make products that meet our customer expectations for quality and durability. For further questions please call (269) 389-6927

Root cause

PMA

Status

Terminated

Product code

ILK

Quantity affected

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 Ca

Date initiated

2012-06-27

Date posted

2012-08-22

Date terminated

2013-12-30

Location

Portage, MI