GE HealthCare OEC 9900 Elite C-arm Systems recallZ-2342-2025 · GE Medical Systems, LLC · initiated Jul 2, 2025
Open, Classified
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 Medical 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
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
GE HealthCare will send a customer letter providing safety instructions as an immediate mitigation, to communicate the risk of additional radiation and that the equipment should only be used by personnel properly trained and authorized in the use of ionizing radiation. A user should observe proper safety practices during equipment operation as required by the operator manual. GE HealthCare will correct all affected OEC 9800 and OEC 9900 Elite systems (28 units) by visually inspecting for the presence of lead shield tape on the collimator cover and replacing the collimator cover if it is found non-compliant, at no cost to the customer.
Recall details
- Recall number
- Z-2342-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 2, 2025
- Posted by the FDA
- Aug 22, 2025
- Recalling firm
- GE Medical Systems, LLC
- Product code
- OWB
- FDA submissions
- K073543, K122234, K082781, K120613
- Distribution
- US Nationwide distribution.
Product description
GE HealthCare OEC 9900 Elite C-arm Systems.
Code information (models, lots, serial numbers)
GTIN: 00840682114349
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OEC 9800 PLUSOec Medical Systems, Inc. · Interventional fluoroscopic x-ray system5 recalls0 reports
Other devices under the same FDA submission
1 device cleared under K073543, K122234, K082781, K120613 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- OEC 9900 ELITEOec Medical Systems, Inc. · Interventional fluoroscopic x-ray system3 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97454).
- Z-2341-2025 · Open, ClassifiedGE HealthCare OEC 9800.
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.
How recalls are matched to devices · Editorial policy · Report an error on this page