Recall Z-0921-2007 ยท FRW Scale, Patient
Integrated Measurement Systems, Inc.
IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4pt-WSC and HOY-StatureWSC
| Date | Jun 19, 2007 (initiated Jan 30, 2007) |
| Status | Terminated |
| Reason | Patient Scale may become detached, which can cause a patient to fall and result in injury. |
| 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 noti |
| Quantity | 149 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.