Recall record at a glance
| Official record | Z-2246-2012 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Stryker Medical Division of Stryker Corporation |
| Report date | Aug 29, 2012 |
| Recall initiation date | Jun 27, 2012 |
| Quantity | 159 units |
| Location | Portage, MI, United States |
Official product description
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.
Why the product was recalled
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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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