Optima URS X-Ray System recallZ-0652-03 · Sedecal USA, Inc. · initiated Sep 24, 2002
Terminated All recalls posted in April 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sedecal USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0652-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 24, 2002
- Posted by the FDA
- Apr 25, 2003
- Recalling firm
- Sedecal USA, Inc.
- Quantity
- 5 units
- Product code
- KPR--
- FDA submissions
- K012546
- Distribution
- New York, Texas, Florida and Minnesota.
Product description
Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
Code information (models, lots, serial numbers)
serial numbers G14698, G14689, G14501, G14932, G14835
Other devices under the same FDA submission
2 devices cleared under K012546 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SEDECAL SEDECAL X URSSedecal · System, X-Ray, Stationary1 recall0 reports
- SEDECAL SEDECAL X (URS)Sedecal · System, X-Ray, Stationary1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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