Lumbar Matrix Scan, Diagnostic Electromyography System consisting of the CERSR Electromyography System and Electrode Arr
FDA device recall Z-1935-2010 · posted 2010-06-30 · Terminated
Recall details
- Recalling firm
- SpineMatrix Inc
- 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,
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IKN
- Quantity affected
- CERSR - 14 units, Electrode Arrays - 1,152 units
- Distribution
- Nationwide Distribution -- CA, OH, OR & TX.
- Date initiated
- 2010-01-29
- Date posted
- 2010-06-30
- Date terminated
- 2012-09-19
- Location
- Akron, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CERSR ELECTROMYOGRAPHY SYSTEM (K990766) | Paraspinal Diagnostic Corp. | 1999-08-27 |