FDA Medical Device Recalls (openFDA)
Sedecal USA, Inc.: Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
- Recall number
- Z-0649-03
- Recalling firm
- Sedecal USA, Inc.
- Product
- Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
- Status
- Terminated
- Initiated
- 2002-09-26
- Posted
- 2003-04-25
- Terminated
- 2006-09-27
- Reason
- Incorrect indentification labels and their certification testing program failed in noncompliance with the U.S. Federal performance standard.
- Root cause
- Other
- Action
- Sedecal USA sent end user notification letters dated 9/26/02 to the consignees having the affected Sedecal X-Ray High Voltage Generators and X-Ray Controls, 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. The accounts were told that once Sedecal has conducted performance tests on selected generators and controls to verify their compliance with the federal performance standard and analyzed that data, they will be able to complete their corrective action plan and contact the accounts with additional information. 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
- 199 units
- Distribution
- Nationwide, Mexico, Poland, Japan, Abu Dahbi, Venezuela, Australia, Denmark, Panama, Korea, Columbia, and Africa.
- Lot, serial or model codes
- Model SHF210, serial numbers G13360, G13782, G13810, G13812, G13814, G13815; Model SHF310, serial numbers G13058, G13269, G13335, G13336, G13361, G13364, G13367, G13430, G13536, G13441, G13442, G13550, G13553, G13577, G13587, G13591, G13595, G13605, G13648, G13651, G13653, G13656, G13790, G13800, G13822, G13854, G13855, G13856, G13868, G13930, G13932, G14023, G14029, G14032, G14034, G14035, G14037, G14038, G14039, G14321, G14325, G14326, G14328, G14332, G14391, G14394, G14558, G14576, G14577, G14581, G14584, G14585, G14675, G14727, G14731, G14734, G14736, G14737, G14738, G14740, G14767, G14768, G14780, G14781, G14782, G14785, G14786, G14820, G14821, G14794, G14795, G14796, G14798, G14800, G14837, G14850, G14873, G14874, G14989; Model SHF310RF, serial numbers G13404, G13547; Model SHF310LS, serial numbers G13405, G13429, G14354; Model SHF310AEC, serial number G14028; Model SHF310PSU, serial numbers G14359, G14569, G14607; Model SHF315, serial number G14926; Model SHF320, serial numbers G13314, G13437, G13453, G13467, G13476, G13483, G13491, G13524, G13525, G13544, G13551, G13556, G13558, G13560, G13563, G13718, G13722, G13738, G13739, G13806, G13809, G13813, G13816, G13823, G13944, G13946, G13956, G13957, G14271, G14274, G14367, G14762, G14763, G14829, G15019, G15023; Model SHF320F, serial number G13270; Model SHF320RF, serial numbers G14016, G14019, G14027; Model SHF320CE, serial numbers G14453, G14455, G14847, G14853; Model SHF320LS, serial number G14051; Model SHF330, serial numbers G13303, G14171, G14249, G14324, G14343, G14969; Model SHF410, serial numbers G13357, G13537, G13992, G14037, G14053, G14313, G14328, G14813; Model SHF410RF, serial number G14538; Model SHF420, serial numbers G13760, G14013, G14269, G14329; Model SHF420RF, serial numbers G14047, G14621, G14885; Model SHF430RF, serial number G14620; Model SHF510, serial numbers G14490, G14529, G14668, G14876, G14904; Model SHF510LS, serial numbers G14167, G14169; Model SHF520, serial numbers G13527, G13581, G13704, G14210, G14317; Model SHF520RF, serial numbers G14317, G14669, G14881; Model SHF520LS, serial number G13918; Model SHF525RF, serial numbers G14248, G13251; Model SHF530, serial number G13574; Model SHF530LS, serial number G14728; Model SHF535, serial numbers G13233, G13273, G14869, G14869; Model SHF625, serial number G13378; Model SHF630, serial numbers G13230, G14345, G14670, G14971; Model SHF630RF, serial numbers G14392, G14747; Model SHF635, serial number G14395; Model SHF835, serial numbers G13724, G14507; Model SHF835RF, serial numbers G13240, G13240
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IZO--
- 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