Centricity Universal Viewer 6.0, a device that displays… recallZ-0819-2020 · GE Healthcare, LLC · initiated Dec 16, 2019
Class II Terminated All recalls posted in January 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0819-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 16, 2019
- Posted by the FDA
- Jan 17, 2020
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 205
- Product code
- LLZ
- FDA submissions
- K150420, K182419
- Distribution
- Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
Product description
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Code information (models, lots, serial numbers)
Model 2088026-9XX Versions 6.0 SP10 or higher
Other devices under the same FDA submission
1 device cleared under K150420, K182419 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CENTRICITY UNIVERSAL VIEWER 6.0Ge Healthcare · System, image processing, radiological8 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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