Lumbar Matrix Scan, Diagnostic Electromyography System consisting of the CERSR Electromyography System and Electrode Array; the system consists 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 is adhered to the patient for monitoring the bioelectric signals produced by the muscles. The disposable is
Hazard
A full design review of the CERSR system was conducted in 7/2009. The audit 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 patients scan, but were actually reviewing a scan from a different patient. This event did not happen; however,
What You Should Do
On 1/29/2010 all customers were provided a Voluntary Product Recall Notification letter that was sent via U.S. Postal Service Certified Mail and they were contacted by phone to arrange for pick up of the devices. The letter identified the affected product and described the problem. Customers are to check their inventory for the affected product and contact SpineMatrix Customer Service to receive instruction as to how to return the affected product, if the firm did not already contact the customer. Customers must complete the verification form and return it. Questions should be directed to Customer Service.
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Products
- Brand
- SpineMatrix Inc
- UPC
- Model Number(s): AM-0001-08-0 (CERSR) and 02003 (Electrode Array). CERSR serial numbers - 1,3, 6, 8, 9, 11, 12, 12a, 13, 14, 17, 19, 20, 21, and 23. Electrode Array lot numbers: 112607-01, 112007-01, 112807-01, 112907-01, 120407-01, 120607-01, 120707-01, 121007-01, 121107-01, 121207-01, 121307-01, 030508-01, 031108-01, 031208-01, 031308-01, 031408-01, 031708-01, 031808-01, 032608-01, 032708-01, 032808-01, 040308-01, 040408-01, 040708-01, 041008-01, 041108-01, 041409-01, 041609-01, 111008-01, 111208-01, 111708-01, 071309-01, 111308-01, 111808-01, 041309-01, 041409-01, 091009-01, & 111309-01.
Units Affected
CERSR - 14 units, Electrode Arrays - 1,152 units