Standard Imaging Inc. Exradin A12 Ionization Chamber Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Exradin A12 Ionization Chamber
Brand
Standard Imaging Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Standard Imaging Inc. is recalling Exradin A12 Ionization Chamber due to Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026