GE HealthCare OEC C-Arm Systems: Missing Lead Shielding Increases Radiation Exposure
GE Medical Systems is recalling certain OEC 9800 and OEC 9900 Elite C-arm systems with missing lead tape in collimator covers, causing small increases in radiation exposure to patients and operators. The defect is not detectable by users.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving undetectable shielding defects that cause measurable increases in radiation exposure. Although no injuries, illnesses, or hospitalizations have been reported, this qualifies as a risk-of-harm product (radiation exposure to patients and operators) where injury has not yet occurred, per the rubric.
Plain-English summary
GE Medical Systems, LLC is recalling certain OEC 9800 and OEC 9900 Elite C-arm systems distributed nationwide in the United States. These radiographic imaging systems contain a manufacturing defect: missing full layers of lead tape in the collimator covers, which violates FDA regulations (21 CFR 1020.30(k)).
The missing lead tape results in a small increase in radiation exposure to patients undergoing imaging procedures and to medical personnel operating the equipment. The defect cannot be detected by visual inspection or user testing.
Healthcare facilities using affected OEC 9800 or OEC 9900 Elite systems should contact GE Medical Systems, LLC to verify whether their equipment is impacted and for information about repair or replacement options.
The recalled product
- Product
- GE HealthCare OEC 9800.
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- radiation-exposure
- lead-shielding-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 00840682114349
Distribution
Distributed nationwide across the United States.
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