The device is labeled in part: " RS Medical RS-4i Stimulator". The device is sold in a kit that includes a carrying case

FDA device recall Z-0323-2011 · posted 2010-11-08 · Terminated

Recall details

Recalling firm

International Rehabilitative Sciences, Inc.

Reason for recall

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.

Action taken

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 around two years of use, and the battery should not be replaced by patients. On 10/29/10, the firm began sending out URGENT NOTICE of VOLUNTARY RECALL letters to their customers. The firm will continue to send out the letters through 2011. The letter states the recall product as RS-4i Sequential Stimulator, Affected Serial Numbers 4i300000 to 4i467119. The customers are informed that "RS-4i Sequential Stimulators, only those within the affected serial number range indicated above, are susceptible to early expiration of the lithium coin cell battery that provides back-up power to the device memory when the stimulator is powered OFF. Customer experience indicates that the 3V lithium coin cell battery can be depleted as early as one third of its rated life. The RS-4i Stimulator will perform as intended until the lithium coin cell battery is fully depleted. When this happens, the Stimulator will turn OFF and fail to turn ON, even if it has been charged by battery charger connection to a standard electrical wall outlet". Customers are advised to make a schedule for a free Return and Repair of a RS-4i Sequential Stimulator and should call the Toll Free Service Line at 877-363-5753 (English) or 877-363-5754 (Spanish) from 6AM to 5PM (Pacific Time) Monday-Friday. If the customers have any other questions or to review additional information before scheduling a device

Root cause

Other

Status

Terminated

Product code

IPF

Quantity affected

166, 131 units

Distribution

Nationwide Distribution

Date initiated

2008-06-11

Date posted

2010-11-08

Date terminated

2012-09-10

Location

Vancouver, WA

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