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U.S. Department of Health and Human Services

Class 2 Device Recall IMS Patient scale

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 Class 2 Recall
IMS Patient scale
see related information
Date Posted June 19, 2007
Recall Status1 Terminated on March 02, 2008
Recall Number Z-0921-2007
Recall Event ID 37774
Product Classification Scale, Patient - Product Code FRW
Product IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4pt-WSC and HOY-StatureWSC
Code Information All serial numbers for Model No. HOY-4PTWSC and HOY-STATUREWSC
Recalling Firm/
Manufacturer
Integrated Measurement Systems, Inc.
440 Bonnie Ln
Elk Grove Village, Illinois 60007-1908
Manufacturer Reason
for Recall
Patient Scale may become detached, which can cause a patient to fall and result in injury.
FDA Determined
Cause 2
DESIGN: Device Design
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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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