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Terminated

Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.

FDA Recall Z-0819-2020 · Posted 2020-01-17

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2019-12-16
Date Terminated2023-10-05
Product Quantity205

Reason for Recall

Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.

Firm Action

The firm initiated their correction on 12/16/2019 by letter. The letter explained the issue and directed the consignee to follow instructions in the letter until an update to the Centricity Universal Viewer can be made by the firm to correct the issue.

Root Cause

Software design

Distribution Pattern

Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K182419Centricity Universal ViewerGE Healthcare · 2018-12-14

Official Source

View FDA Recall →

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

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