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Terminated

Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.

FDA Recall Z-0195-2019 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2018-08-30
Date Terminated2022-08-31
Product Quantity1

Reason for Recall

Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.

Firm Action

On August 30, 2018, GE Healthcare sent Urgent Medical Device Correction letters to customers with affected units. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. 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.

Root Cause

Component design/selection

Distribution Pattern

NY

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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