FDA Device recall Z-1863-2012
Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both general patient care as well as critical care environments
- FDA Device
- Class II
- terminated
- Published 2012-07-04
On 2012-07-04 the FDA classified a Class II recall of Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both general patient care as well as critical care environments by Stryker Medical Division, citing 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 failur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1863-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-17 |
| Published | 2012-07-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Medical Division |
| Distribution | US |
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 of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
Reason
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
Identifiers
| code_info | Model FL28EX, Serial Numbers: QR09842, QM10376, QM10375, QM10374, QM10373, QM10372, QM10371, QM10370, QM10369, QM10368,…Model FL28EX, Serial Numbers: QR09842, QM10376, QM10375, QM10374, QM10373, QM10372, QM10371, QM10370, QM10369, QM10368, QM10367, QM10366, QM10365, QM10364, QM10363, QM10362, QM10361, QM10360, QM10359, QM10358, QM10357, QM10356, QM09893, QM09883, QM09829, QM09827, QM09805, QM09804, QM09803, QM09802, QM09801, QM09800, QM09799, QM09798, QM09797, QM09796, QM09795, QM09794, QM09793, QM09444, QM08965, QM08916, QM08832, QM08230, QM08211, QM08210, QM08209, QM08208, QM08207, QM08206, QM08205, QM08204, QM08203, QM08202, QM08201, QM08200, QM08199, QM08198, QM08197, QM08142, QM08136, QM08135, QM08003, QM07962, QM07879, QM07613, QM07451, QM07448, QM07447, QM07446, QM07442, QM07357, QM07149, QM07148, QM07143, QM07141, QM07140, QM06967, QM06830, QM06041, QM06040, QM06039, QM06038, QM06037, QM06036, QM06035, QM06034, QM06033, QM06032, QM06031, QM06030, QM06029, QM06028, QM06027, QM06026, QM06025, QM06024, QM06023, QM06022, QM06021, QM06020, QM06019, QM06018, QM06017, QM06016, QM06015, QM06014, QM06013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1863-2012%22
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