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U.S. Department of Health and Human Services

Class 2 Device Recall Sedecal Easy Moving Mobile XRay Unit

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  Class 2 Device Recall Sedecal Easy Moving Mobile XRay Unit see related information
Date Initiated by Firm September 26, 2002
Date Posted April 25, 2003
Recall Status1 Terminated 3 on July 29, 2005
Recall Number Z-650/51-03
Recall Event ID 26110
510(K)Number K012663  
Product Classification unknown device name - Product Code IZL--
Product Easy Moving Motor Driven Mobile X-Ray Unit, Models SM-20HF and SM-30HF; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
Code Information Model SM-20HF, serial numbers G13487, G13457; Model SM-30HF, serial numbers G12468, G13449, G13540, G13747, G13765, G14097, G14099, G14633, G15025
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 identification labels and failure of the cretification testing resulting 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 Mobile 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 in Commerce 9 units
Distribution North Carolina, Louisiana, New York, New Jersey, Missouri, Kentucky, Texas and Germany
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.
510(K) Database 510(K)s with Product Code = IZL-- and Original Applicant = SEDECAL USA, INC.
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