Recall Z-0652-03 ยท KPR System, X-Ray, Stationary
Sedecal USA, Inc.
Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
| Date | Apr 25, 2003 (initiated Sep 24, 2002) |
| Status | Terminated |
| Reason | Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards. |
| Root cause | Other |
| Action | Sedecal USA sent end user notification letters dated 9/24/02 to the consignees having the affected Sedecal Stationary X-Ray Systems, 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. Sedecal schedule an appointment to conduct performance tests on the mobile x-ray systems to verify their compliance with the federal performance standard, submit the data to FDA, and place the English labels on the units. Sedecal will reimburse the owners for any out-of-pocket exp |
| Quantity | 5 units |
| Distribution | New York, Texas, Florida and Minnesota. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012546 | OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM Sedecal USA, Inc., Nov 2, 2001 |