In the Enforcement Report for July 21, under Recalls and Field Corrections: Devices—Class II, the FDA lists the ongoing recall of the lumbar matrix scan, diagnostic electromyography system.

Consisting of two devices, the first is a system of capital equipment referred to as CERSR electromyography system, which includes a cart. The second device is disposable electrodes arrays, which are single use devices—used with the capital equipment—that are adhered to the patient for monitoring the bioelectric signals produced by the muscles.

SpineMatrix Inc, Akron, Ohio, initiated the recall in January because a full design review of the CERSR system in 2009 revealed numerous design verification tests that either did not pass or did not meet the design input requirement. One requirement found that it was possible for the physician to think they were reviewing one patient’s scan, but were actually reviewing a scan from a different patient. This event did not happen; however, the possibility was there, which resulted in this recall.

For complete information on the units, distributed in California, Ohio, Oregon, and Texas, view the Enforcement Report online.

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