Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2248-2012Class II

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

Stryker Medical / initiated 2012-06-27 / Terminated / root cause: manufacturing process

Stryker Medical Division of Stryker Corporation began a recall of 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... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2248-2012
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
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 effort and risk of back injury while transporting a patient up or down a set of stairs
Product code
ILK Transport, Patient, Powered
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.
Root cause tag
manufacturing process
FDA 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 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
Quantity in commerce
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.
Product codes and lots
Model: HHC with serial codes: 100391, 100394, 100397, 100401, 100403, 100404, 100405, 100407, 100408, 100409, 100411, 100413, 100414, 100416, 100417, 100418, 100419, 100420, 100421, 100422, 100423, 100424, 100425, 100426, 100427, 100428, 100430, 100430, 100431, 100433, 100434, 100435, 100436, 100437, 100438, 100439, 100440, 100441, 100442, 100443, 100444, 100445, 100446, 100447, 100448, 100449, 100450, 100452, 100453, 100454, 100455, 100456, 100457, 100458, 100459, 100461, 100462, 100463, 100464, 100465, 100466, 100467, 100468, 100469, 100470, 100471, 100472, 100473, 100540, and 100543.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2248-2012
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2246-2012Class IITerminatedVoluntary: Firm initiated
Z-2247-2012Class IITerminatedVoluntary: Firm initiated
Z-2248-2012Class IITerminatedVoluntary: Firm initiated
Z-2249-2012Class IITerminatedVoluntary: Firm initiated