Z-0952-03

Exradin A12 Ionization Chamber

Name: Z-0952-03 Exradin A12 Ionization Chamber
Creator: Standard Imaging Inc.
Published: 2003-05-28
License: https://open.fda.gov/license/

Standard Imaging Inc. / initiated 2003-05-28 / Terminated / root cause: manufacturing process

FDA source

Standard Imaging Inc. began a recall of Exradin A12 Ionization Chamber on 2003-05-28. The reason FDA records is "Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0952-03
Status: Terminated
Initiated: 2003-05-28
Posted: 2003-06-27
Terminated: 2004-07-02
Recalling firm: Standard Imaging Inc.
Product: Exradin A12 Ionization Chamber
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: 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

Product code IYE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)