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Terminated

Exradin A12 Ionization Chamber

FDA Recall Z-0952-03 · Posted 2003-06-27

Recalling FirmStandard Imaging Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2003-05-28
Date Terminated2004-07-02
Product Quantity25 units

Reason for Recall

Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors.

Firm 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.

Root Cause

Process design

Distribution Pattern

The product was shipped to 24 hospitals located nationwide in the United States.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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