Medical Device Recall: Z-0012-2022

FDA Recalls dataset · Firm: GE Healthcare, LLC · Status: Terminated

Recall Action Class: N/A Date Initiated: 2021-08-12 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0012-2022.

Recall Res Number
Z-0012-2022
Recalling Firm / Manufacturer
FEI Number
2126677
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2021-08-12
Date Posted
2021-10-02
Date Terminated
2024-08-22
Product Code
LLZ
Event Number
88595
Product Quantity
49
Product Description Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

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).

Action Details This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 13, 2021. This letter informs customers of the issues and provides safety instructions. GE Healthcare will correct the issue through a product change. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Distribution Pattern 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

Code Information / Serial Numbers Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794

Related Establishments / Registrations

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