Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
Reported: November 1, 2023 Initiated: September 14, 2023 #Z-0139-2024
Product Description
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
Reason for Recall
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
Details
- Recalling Firm
- GE Healthcare
- Units Affected
- 17 units
- Distribution
- US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Netherlands Antilles, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, Vietnam
- Location
- Chicago, IL
Frequently Asked Questions
What product was recalled? ▼
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System. Recalled by GE Healthcare. Units affected: 17 units.
Why was this product recalled? ▼
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 1, 2023. Severity: Moderate. Recall number: Z-0139-2024.
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