The Recall Desk

FDA (Devices) recall action 61712

Stryker Medical Division of Stryker Corporation recalled 5 products on 2012-07-04

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2012-07-04
Critical
0
Units
27,319

Why these products were recalled

An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac

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

1–5 of 5

  • ModerateFDA (Devices)··2012-07-04

    Stryker Recalls Go Bed II+ Model FL 28 Ex Due to Scale Failures

    Stryker is recalling 9,440 Go Bed II+ Model FL 28 Ex hospital beds due to an abnormally high failure rate of loadcells, which can cause scale errors or disabled functions.

    Product
    Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-07-04

    Stryker Recalls GoBed+ Model FL20E Hospital Beds Due to Scale Failures

    Stryker is recalling 6,325 GoBed+ Model FL20E hospital beds worldwide because loadcell failures can cause scale errors or disable bed exit functions.

    Product
    GoBed+ . Model FL20E Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of th
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2012-07-04

    Stryker MA204 Bed Recall Due to Loadcell Failure in Scale Function

    Stryker is recalling MA204 beds because loadcells in the scale and bed exit systems are failing at an abnormally high rate.

    Product
    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface co
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2012-07-04

    Stryker Recalls Go Bed II+ Units Due to Scale and Bed Exit Failures

    Stryker is recalling 8,009 Go Bed II+ Model FL28C hospital beds worldwide due to a high failure rate of loadcells that affects scale and bed exit functions.

    Product
    Go Bed II+ Model FL28C Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-07-04

    Stryker Rose Bed Recall Due to Loadcell Failure in Scale Function

    Stryker is recalling Rose Model FL14E beds because loadcell failures cause scale errors and disabled bed exit functions.

    Product
    Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface co
    Category
    Distribution
    1 state