The Recall Desk

FDA (Devices) recall action 61671

Stryker Medical Division of Stryker Corporation recalled 4 products on 2012-08-29

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2012-08-29
Critical
0
Units
636

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • LowFDA (Devices)··2012-08-29

    Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues

    Stryker is recalling 159 Powered MOV Chairs due to potential compliance issues regarding product documentation and classification identified during a merger review.

    Product
    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 pro
    Category
    Distribution
    26 states
  • ModerateFDA (Devices)··2012-08-29

    Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues

    Stryker is recalling 159 Powered MOV Chairs due to potential compliance issues in product documentation and classification identified during a merger review.

    Product
    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 pr
    Category
    Distribution
    26 states
  • ModerateFDA (Devices)··2012-08-29

    Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues

    Stryker is recalling 159 Powered MOV Chairs to address potential compliance issues regarding product documentation and classification identified during a merger review.

    Product
    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 pr
    Category
    Distribution
    26 states
  • ModerateFDA (Devices)··2012-08-29

    Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues

    Stryker is recalling 159 Powered MOV Chairs to address potential compliance issues regarding product documentation and classification identified during a corporate merger.

    Product
    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 pro
    Category
    Distribution
    26 states