Easy Moving Motor Driven Mobile X-Ray Unit, Models SM-20HF and SM-30HF; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio
FDA device recall Z-650/51-03 · posted 2003-04-25 · Terminated
Recall details
- Recalling firm
- Sedecal USA, Inc.
- Reason for recall
- Incorrect identification labels and failure of the cretification testing resulting in noncompliance with the U.S> Federal performance standard
- Action taken
- 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 expenses incurred. Sedecal requested the accounts to call 800-920-9525 if they had any questions, and to inform Sedecal if they sold the unit, destroyed the unit or otherwise no longer had the unit in their possession.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 9 units
- Distribution
- North Carolina, Louisiana, New York, New Jersey, Missouri, Kentucky, Texas and Germany
- Date initiated
- 2002-09-26
- Date posted
- 2003-04-25
- Date terminated
- 2005-07-29
- Location
- Arlington Heights, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) (K012663) | Sedecal USA, Inc. | 2001-08-31 |