Class 3 Device Recall Exradin

• Date Initiated by Firm: May 28, 2003
• Date Posted: June 27, 2003
• Recall Status: Terminated 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: 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.