Centricity PACS Software Version 7.0 SP0.0.4.7
Reported: August 3, 2022 Initiated: June 14, 2022 #Z-1466-2022
Product Description
Centricity PACS Software Version 7.0 SP0.0.4.7
Reason for Recall
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 47 installations
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and United Kingdom.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Centricity PACS Software Version 7.0 SP0.0.4.7. Recalled by GE Healthcare, LLC. Units affected: 47 installations.
Why was this product recalled? ▼
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2022. Severity: Moderate. Recall number: Z-1466-2022.
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