GE Healthcare Definium 5000 / 5220493 X-Ray System
Reported: March 6, 2013 Initiated: September 26, 2012 #Z-0703-2013
Product Description
GE Healthcare Definium 5000 / 5220493 X-Ray System
Reason for Recall
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 312 installed in US
- Distribution
- Nationwide Distribution
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare Definium 5000 / 5220493 X-Ray System. Recalled by GE Healthcare, LLC. Units affected: 312 installed in US.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2013. Severity: Moderate. Recall number: Z-0703-2013.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11