Z-0649-03

Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De...

Name: Z-0649-03 Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De...
Creator: Sedecal USA, Inc.
Published: 2002-09-26
License: https://open.fda.gov/license/

Sedecal USA, Inc / initiated 2002-09-26 / Terminated / root cause: labeling and UDI

FDA source

Sedecal USA, Inc. began a recall of Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN on 2002-09-26. The reason FDA records is "Incorrect indentification labels and their certification testing program failed in noncompliance with the U.S. Federal performance standard". 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-0649-03
Status: Terminated
Initiated: 2002-09-26
Posted: 2003-04-25
Terminated: 2006-09-27
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
Product code: IZO--
Reason for recall: Incorrect indentification labels and their certification testing program failed in noncompliance with the U.S. Federal performance standard.
Root cause tag: labeling and UDI
FDA 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 in commerce: 199 units
Distribution: Nationwide, Mexico, Poland, Japan, Abu Dahbi, Venezuela, Australia, Denmark, Panama, Korea, Columbia, and Africa.
Product codes and lots: 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

Product code IZO--

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)