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U.S. Department of Health and Human Services

Class 3 Device Recall Exradin

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  Class 3 Device Recall Exradin see related information
Date Initiated by Firm May 28, 2003
Date Posted June 27, 2003
Recall Status1 Terminated 3 on July 02, 2004
Recall Number Z-0952-03
Recall Event ID 26445
Product Classification Accelerator, Linear, Medical - Product Code IYE
Product Exradin A12 Ionization Chamber
Code Information Serial numbers XA030414, XA030413, XA030412, XA030411, XA030281, XA030225, XA030224, XA023341, XA023251, XA022101, XA021649, XA021645, XA021642, XA021641, XA020741, XA020176, XA020171, XA020143, XA013118, XA012743, XA012741, XA011444, XA392, 390, and  345 
Recalling Firm/
Manufacturer		 Standard Imaging Inc.
7601 Murphy Rd
Middleton WI 53562
For Additional Information Contact Raymond T. Riddle
608-831-0025 Ext. 262
Manufacturer Reason
for Recall		 Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors.
FDA Determined
Cause 2		 Process design
Action The consignees were telephoned on May 28, 2003 and informed of the problem and recall, and sent a recall letter, dated May 28, 2003, requesting the return of the product.
Quantity in Commerce 25 units
Distribution The product was shipped to 24 hospitals located nationwide in the United States.
Total Product Life Cycle TPLC Device Report
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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