Proteus XR/a (SlOK : K993090) recallZ-2449-2019 · GE Healthcare, LLC · initiated Aug 9, 2019
Class II Open, Classified All recalls posted in September 2019
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
Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
FDA root cause category: Device Design
What the company is doing
GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. 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- 800-437-1171or your local Service Representative.
Recall details
- Recall number
- Z-2449-2019
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Aug 9, 2019
- Posted by the FDA
- Sep 20, 2019
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 647 US; 167 OUS
- Product code
- KPR
- FDA submissions
- K993090
- Distribution
- Worldwide - US Nationwide
Product description
Proteus XR/a (SlOK : K993090)
Code information (models, lots, serial numbers)
console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)
Other devices under the same FDA submission
1 device cleared under K993090 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Proteus XRaGE Hualun Medical Systems Co., Ltd · System, x-ray, stationary2 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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