Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0921-2007

IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models...

Integrated Measurement Systems, Inc. / initiated 2007-01-30 / Terminated

Integrated Measurement Systems, Inc. began a recall of IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4pt-WSC and HOY-StatureWSC on . The reason FDA records is "Patient Scale may become detached, which can cause a patient to fall and result in injury". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0921-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Integrated Measurement Systems, Inc.
Product
IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4pt-WSC and HOY-StatureWSC
Product code
FRW Scale, Patient
Reason for recall
Patient Scale may become detached, which can cause a patient to fall and result in injury.
FDA root cause
Other
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.
Quantity in commerce
149 units
Distribution
Worldwide
Product codes and lots
All serial numbers for Model No. HOY-4PTWSC and HOY-STATUREWSC