FDA Medical Device Recalls (openFDA)
Standard Imaging Inc.: Exradin A12 Ionization Chamber
- Recall number
- Z-0952-03
- Recalling firm
- Standard Imaging Inc.
- Product
- Exradin A12 Ionization Chamber
- Status
- Terminated
- Initiated
- 2003-05-28
- Posted
- 2003-06-27
- Terminated
- 2004-07-02
- Reason
- Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors.
- 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
- 25 units
- Distribution
- The product was shipped to 24 hospitals located nationwide in the United States.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1000115748
- Firm city
- Middleton
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28