510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1935-2010

Lumbar Matrix Scan, Diagnostic Electromyography System consisting of the CERSR Electromyography System and...

Spinematrix, Inc. / initiated 2010-01-29 / Terminated / root cause: design
FDA source (opens on fda.gov)

SpineMatrix Inc began a recall of Lumbar Matrix Scan, Diagnostic Electromyography System consisting of the CERSR Electromyography System and Electrode Array; the system consists of two devices... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1935-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Spinematrix, Inc.
Product
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 referred to as the Electrode Array. CERSR Electromyography System is packaged in a reusable crate maintained by SMI. The Electrode Array is packaged in a sealed foil pouch. Both devices are non-sterile and the packaging is for protection from damage during shipping.
Product code
IKN Electromyograph, Diagnostic
Reason for recall
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,
Root cause tag
design
FDA root cause
Device Design
Action
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.
Quantity in commerce
CERSR - 14 units, Electrode Arrays - 1,152 units
Distribution
Nationwide Distribution -- CA, OH, OR & TX.
Product codes and lots
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.