GE Healthcare Proteus XR/a General Purpose Radiographic… recallZ-1087-2007 · General Electric Med Systems LLC · initiated May 31, 2006
Terminated All recalls posted in September 2007
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
Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled.
FDA root cause category: Other
What the company is doing
Consignees were notified of the problem by a visit. To address the Proteus System shipped to the field, a Field Modification (FMI) was created to correct units in the field.
Recall details
- Recall number
- Z-1087-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 31, 2006
- Posted by the FDA
- Sep 25, 2007
- Recalling firm
- General Electric Med Systems LLC
- Quantity
- 22 units
- Product code
- KPR
- FDA submissions
- K993090
- Distribution
- Nationwide; including states of WA,KS, CO, NM, NC, FL, MT, AZ, TX, IL, NY, MD, and GA
Product description
GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976.
Code information (models, lots, serial numbers)
30920HL3, 30921HL1, 31931HL9, 3457OHL2, 34864HL9, 34911HL8, 35136HL1, 35191HL6, 35244HL3, 35936HL4, 36207HL9, 36361HL4, 36431HL5, 36521HL3, 36702HL9, 36704HL5, 37009HL8, 37261HL5, 37395HL1, 37396HL9, 37597HL2 & 993702WK0
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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