Proteus XR/a Radiographic X-ray System, models 2259973-1… recallZ-0219-05 · General Electric Med Systems LLC · initiated Dec 30, 2004
Terminated All recalls posted in February 2006
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 General Electric Med Systems 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
Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.
FDA root cause category: Other
What the company is doing
An 'Urgent: Radiation Safety Notice' letter was issued to hospitals with affected systems describing potential hazards, the planned modification and recommended action to limit the hazard until the planned modification is installed. A GE field Service Representative will install the modification.
Recall details
- Recall number
- Z-0219-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 30, 2004
- Posted by the FDA
- Feb 14, 2006
- Recalling firm
- General Electric Med Systems LLC
- Quantity
- 2716
- Product code
- KPR
- FDA submissions
- K993090
- Distribution
- globally
Product description
Proteus XR/a Radiographic X-ray System, models 2259973-1, 2259973-2, 2259973-3, 2259973-4. The system consists of a radiographic table, a overhead tube suspension, high frequency generator and power distribution unit, wall stand, dual focal spot x-ray tube and operator''s console.
Code information (models, lots, serial numbers)
all serial numbers
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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