Recall Z-0649-03 ยท IZO Generator, High-Voltage, X-Ray, Diagnostic
Sedecal USA, Inc.
Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
| Date | Apr 25, 2003 (initiated Sep 26, 2002) |
| Status | Terminated |
| Reason | Incorrect indentification labels and their certification testing program failed in noncompliance with the U.S. Federal performance standard. |
| Root cause | Other |
| Action | Sedecal USA sent end user notification letters dated 9/26/02 to the consignees having the affected Sedecal X-Ray High Voltage Generators and X-Ray Controls, informing them that the units do not meet with the U.S. federal performance standards, that the labels are in Spanish and that the labels may not be visible after system installation. The accounts were told that once Sedecal has conducted performance tests on selected generators and controls to verify their compliance with the federal performance standard and analyzed that data, they will be able to complete their corrective action plan a |
| Quantity | 199 units |
| Distribution | Nationwide, Mexico, Poland, Japan, Abu Dahbi, Venezuela, Australia, Denmark, Panama, Korea, Columbia, and Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.