FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: GE Healthcare Definium 5000/5220493-2 X-Ray System
- Recall number
- Z-0704-2013
- Recalling firm
- GE Healthcare, LLC
- Product
- GE Healthcare Definium 5000/5220493-2 X-Ray System
- Status
- Terminated
- Initiated
- 2012-09-26
- Posted
- 2013-02-27
- Terminated
- 2013-12-05
- Reason
- When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.
- Root cause
- Software design
- Action
- GE Healthcare will remedy the issue or bring the product into compliance with each applicable Federal standard. A GE Healthcare Service Representative will update the software on the system to address the issue. Call Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.
- Quantity
- 312 installed in US
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Definium Model 5000/5220493-2
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAC
- Firm FEI
- 2126677
- Firm city
- Waukesha
- 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