Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
FDA device recall Z-0652-03 · posted 2003-04-25 · Terminated
Recall details
- Recalling firm
- Sedecal USA, Inc.
- Reason for recall
- Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards.
- Action taken
- 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 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
- KPR
- Quantity affected
- 5 units
- Distribution
- New York, Texas, Florida and Minnesota.
- Date initiated
- 2002-09-24
- Date posted
- 2003-04-25
- Date terminated
- 2005-07-29
- Location
- Arlington Heights, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM (K012546) | Sedecal USA, Inc. | 2001-11-02 |