Recall Z-0323-2011 ยท IPF Stimulator, Muscle, Powered
International Rehabilitative Sciences, Inc.
The device is labeled in part: " RS Medical RS-4i Stimulator". The device is sold in a kit that includes a carrying case, connector cables, pads (electrodes), battery charger, patient document, instructional DVD, return mail bag, and the operation manual. This device is used with cables and electrodes that are placed on skin in the treatment area, and allow an electrical micro-current to relieve
| Date | Nov 8, 2010 (initiated Jun 11, 2008) |
| Status | Terminated |
| Reason | The charge current is leaking through two Diodes, which are supposed to block the reverse current, when the device is warm during the main battery charge operation, it then causes the lithium battery to swell around two years of use and it causes the device to be inoperable. |
| Root cause | Other |
| Action | Since June 11, 2008, RS Medical has taken the following actions when the device was sent back through a consumer complaint, or when the device was returned for routine maintenance, or through the rental service. The firm has upgraded the blocking diodes with higher temperature rated diodes, replaced the Lithium coin cell battery, and the software register bit has been changed to denote for subsequent automated testing that the diode upgrade/Lithium coin cell battery replacement has occurred. The firm reported that the device must be returned for the rechargeable NiMH battery replacement ar |
| Quantity | 166, 131 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032652 | RS-4I MUSCLE STIMULATOR FAMILY Rs Medical, Sep 12, 2003 |