Events

Recall of Device Recall Powered Mobility Offers Versatility (MV)TM Chair1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Medical Division of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61671
  • Event Risk Class
    Class 2
  • Event Number
    Z-2246-2012
  • Event Initiated Date
    2012-06-27
  • Event Date Posted
    2012-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108683
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Transport, patient, powered - Product Code ILK
  • 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.
  • 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

Device

Device Recall Powered Mobility Offers Versatility (MV)TM Chair1
  • Model / Serial
    Model number: EMS with serial codes: 100393, 100395, 100400, 100402, 100410, 100451, 100460, 100499, 100500, 100502, 100503, 100504, 100506, 100507, 100508, 100509, 100510, 100511, 100512, 100513, 100514, 100515, 100516, 100517, 100518, 100519, 100522, 100523, 100524, 100525, 100533, 100537, 100538, 100541, 100542, 100544, 100545, 100548, 100549, 100553, 100554, 100555, 100556, 100557, 100559, 100610, 100611, 100612, 100615, 100616, and 100723.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 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.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Manufacturer Address
    Stryker Medical Division of Stryker Corporation, 3800 East Centre Ave., Portage MI 49002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA