FDA Medical Device Recalls (openFDA)
Sedecal USA, Inc.: Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
- Recall number
- Z-0652-03
- 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
- Status
- Terminated
- Initiated
- 2002-09-24
- Posted
- 2003-04-25
- Terminated
- 2005-07-29
- Reason
- Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards.
- 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
- 5 units
- Distribution
- New York, Texas, Florida and Minnesota.
- Lot, serial or model codes
- serial numbers G14698, G14689, G14501, G14932, G14835
- 510(k) numbers
- ["K012546"]
- PMA numbers
- not on file
- Product code
- KPR--
- Firm FEI
- 1000139935
- Firm city
- Arlington Heights
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28