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U.S. Department of Health and Human Services

Class 2 Device Recall Sedecal

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  Class 2 Device Recall Sedecal see related information
Date Initiated by Firm September 26, 2002
Date Posted April 25, 2003
Recall Status1 Terminated 3 on September 27, 2006
Recall Number Z-0649-03
Recall Event ID 26101
Product Classification unknown device name - Product Code IZO--
Product Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
Code Information 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 
Recalling Firm/
Manufacturer		 Sedecal USA, Inc.
2910 N. Arlington Heights Rd
Arlington Heights IL 60004
For Additional Information Contact Mr. Devan Moser
800-920-9525
Manufacturer Reason
for Recall		 Incorrect indentification labels and their certification testing program failed in noncompliance with the U.S. Federal performance standard.
FDA Determined
Cause 2		 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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