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U.S. Department of Health and Human Services

Class 2 Device Recall XCel MB700 A/C

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  Class 2 Device Recall XCel MB700 A/C see related information
Date Initiated by Firm November 12, 2002
Date Posted March 05, 2003
Recall Status1 Terminated 3 on February 28, 2003
Recall Number Z-0424-03
Recall Event ID 25571
Product Classification unknown device name - Product Code KPR--
Product X-Cel MB-700 A/C Podiatry X-Ray System; X-Cel X-Ray Coporation, 4220 Waller Drive, Crystal Lake, IL 60012
Code Information Model MB-700 A/C, srial numbers 622686, 622687, 622688, 622689, 320367, 325120
Recalling Firm/
Manufacturer		 X-Cel X-Ray Corp
4220 Waller Drive
Crystal Lake IL 60012-2848
For Additional Information Contact Mr. William W. Morris
815-455-2470
Manufacturer Reason
for Recall		 The X-Ray system contained a defective X-Ray tube shield.
FDA Determined
Cause 2		 Other
Action Recalled by telephone call on 11/19/2002, with follow-up visits and letters dated 2/27/03. The tube shields were replaced and the x-ray units were recertified.
Quantity in Commerce 3 units
Distribution Northbrook, IL and Frankfort, IL
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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