Z-0652-03

Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid)...

Name: Z-0652-03 Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid)...
Creator: Sedecal USA, Inc.
Published: 2002-09-24
License: https://open.fda.gov/license/

Sedecal USA, Inc / initiated 2002-09-24 / Terminated / root cause: labeling and UDI

FDA source

Sedecal USA, Inc. began a recall of Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN on 2002-09-24. The reason FDA records is "Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0652-03
Status: Terminated
Initiated: 2002-09-24
Posted: 2003-04-25
Terminated: 2005-07-29
Recalling firm: Sedecal USA, Inc
Product: Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
Product code: KPR--
Reason for recall: Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards.
Root cause tag: labeling and UDI
FDA 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 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.
Quantity in commerce: 5 units
Distribution: New York, Texas, Florida and Minnesota.
Product codes and lots: serial numbers G14698, G14689, G14501, G14932, G14835

Product code KPR--

K012546Class IIOptima Urs Universal Radiographic SystemSedecal USA, Inc. / cleared 2001-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)