—#178662

Product

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

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K150420, K182419
Affected lot / code info: Model 2088026-9XX Versions 6.0 SP10 or higher

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated: 2019-12-16
Posted by FDA: 2020-01-17
Terminated: 2023-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178662. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.