Recall Z-650/51-03 ยท IZL System, X-Ray, Mobile
Sedecal USA, Inc.
Easy Moving Motor Driven Mobile X-Ray Unit, Models SM-20HF and SM-30HF; 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 identification labels and failure of the cretification testing resulting 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 Mobile 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 expense |
| Quantity | 9 units |
| Distribution | North Carolina, Louisiana, New York, New Jersey, Missouri, Kentucky, Texas and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012663 | EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) Sedecal USA, Inc., Aug 31, 2001 |