Date Initiated by Firm |
September 24, 2002 |
Date Posted |
April 25, 2003 |
Recall Status1 |
Terminated 3 on July 29, 2005 |
Recall Number |
Z-0652-03 |
Recall Event ID |
26111 |
510(K)Number |
K012546
|
Product Classification |
unknown device name - Product Code KPR--
|
Product |
Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN |
Code Information |
serial numbers G14698, G14689, G14501, G14932, G14835 |
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 their dertification testing program faialed in noncompliance with U.S. Federal performance standards.
|
FDA Determined Cause 2 |
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 in Commerce |
5 units |
Distribution |
New York, Texas, Florida and Minnesota. |
|
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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510(K) Database |
510(K)s with Product Code = KPR-- and Original Applicant = SEDECAL USA, INC.
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