FDAFDA · Food and drugs·Recall number Z-2249-2012
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.
Published August 29, 2012 · Recall initiated: June 27, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Distributor
- 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.
- Lot
- Model: IND with serial codes: 100546, 100547, 100558, 100560, 100561, 100562, 100563, 100564, 100565, 100567, 100568, 100569, 100570, 100571, 100572, 100573, 100574, 100575, 100576, 100577, 100585, 100589, 100592, 100594, 100596, 100620, and 100638.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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