Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Reported: July 24, 2019 Initiated: January 19, 2019 #Z-1951-2019
Product Description
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Reason for Recall
Additional low dose radiation exposure.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 857 (US = 195: OUS = 662)
- Distribution
- Worldwide - US Nationwide Distribution
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.. Recalled by GE Healthcare, LLC. Units affected: 857 (US = 195: OUS = 662).
Why was this product recalled? ▼
Additional low dose radiation exposure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2019. Severity: Moderate. Recall number: Z-1951-2019.
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