GE Healthcare, LLC: Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

Is my product affected?

Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

• UPC 00840682145794

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare has recalled Centricity Universal Viewer 7.0 (Model 5829628-0XX), a radiological image processing system, due to a software anomaly in the study management feature. When users make changes to studies in this software, those changes are not transmitted to either the Centricity Enterprise Archive or other Vendor Neutral Archive systems. The affected software versions are 7.0 SP0.0.4.5 and 7.0 SP0.0.5. A total of 49 units have been distributed across multiple locations in the United States (Arkansas, Illinois, Maine, Mississippi, Nebraska, New Jersey, New York, and Tennessee) as well as internationally in Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Turkey, and the United Kingdom.

The recall source does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).

Details from the source

Reason for recall: A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA). Distribution: AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom Quantity: 49 Lot/code info: Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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