Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
FDA Recall Z-0652-03 · Posted 2003-04-25
Recalling FirmSedecal USA, Inc.
Recall StatusTerminated
Product CodeKPR
Date Initiated2002-09-24
Date Terminated2005-07-29
Product Quantity5 units
Reason for Recall
Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards.
Firm 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.
Root Cause
Other
Distribution Pattern
New York, Texas, Florida and Minnesota.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.