Centricity recallZ-1910-2019 · GE Healthcare, LLC · initiated May 16, 2019
Terminated
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
There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
FDA root cause category: Device Design
What the company is doing
On May 20, 2019, the firm, GE Healthcare, sent an " URGENT MEDICAL DEVICE CORRECTION" letter date 5/20/2019 to their consignees. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: discontinue use of the UV study management functionality for study split/study info updates until a correction is available and to wait for a GE representative to contact them 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.
Recall details
- Recall number
- Z-1910-2019
- Status
- Terminated
- Initiated by the company
- May 16, 2019
- Posted by the FDA
- Jul 1, 2019
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 145 (87 US 103 OUS)
- Product code
- LLZ
- FDA submissions
- K150420, K182419
- Distribution
- Worldwide Distribution: US (nationwide) to states of: FL, GA, IL, IN, LA, MA, MO, NJ, NY, OR, PA, SC, SD, TX, and WA; and countries of : Brazil, Canada, Chile, France, French Polynesia, Germany, India, Italy, Japan, Kuwait, Lebanon, Singapore, Spain and United Kingdom.
Product description
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Code information (models, lots, serial numbers)
UDI # 840682103800 Model # 2098249-002 Software Version: 6.0.9, 6.0SP9.01, CPACS 6.0 SP9.0.1, UV 6.0 SP9.0.1, UV 6.0 SP9.01.1, UV 6.0 SP9.0.1.2, UV 6.0 SP9.01.3, UV6.0 SP9.01.4, UV 6.0 SP9.01.5, UV 6.0 SP9.0.1.6, UV Version 6.0 SP5.0.4.1, UV Version 6.0 SP9, UV Version 6.0 SP9.0.0.1, UV Version 6.0 SP901, UV Version 6.0 SP9011, and UV Version 6.0 SP902
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CENTRICITY UNIVERSAL VIEWER 6.0Ge Healthcare · System, image processing, radiological8 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 82998).
- Z-1911-2019 · TerminatedCentricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and pro…
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 16, 2026. Text above is shown as published by the FDA.
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