IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4pt-WSC and HOY-StatureWSC
FDA Recall Z-0921-2007 · Posted 2007-06-19
Recalling FirmIntegrated Measurement Systems, Inc.
Recall StatusTerminated
Product CodeFRW
Date Initiated2007-01-30
Date Terminated2008-03-02
Product Quantity149 units
Reason for Recall
Patient Scale may become detached, which can cause a patient to fall and result in injury.
Firm Action
The scale manufacturer, IMS, in conjunction with the lift manufacturer, Joerns Healthcare (previously Sunrise Medical), will initiate a field fix strategy consisting of shipping replacement 4-point cradles without scales, for use until a replacement can be designed, tested and validated. Joerns will utilize their Customer Service Help Line (1-800-826-0270) on behalf of IMS, to inform customers of the voluntary field correction, address any questions regarding the IMS scale field fix strategy and to provide additional information on return of affected IMS Patient Scales.
Customers were notified by telephone beginning on January 30, 2007.
Root Cause
Other
Distribution Pattern
Worldwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.