GE OEC Medical Systems, Inc., on behalf of itself and its brand GE OEC, voluntarily recalled 84 mobile OEC 3D REF Image-Intensified Fluoroscopic X-Ray Systems due to a manufacturing issue that may cause oil leaks and loss of imaging capability. The Food and Drug Administration announced the Class II recall on November 21, 2024.
How to tell if you have it
- Brand: GE OEC
- Product Name: OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile
- UPC: 00195278096944
- UPC: 00840682121729
- Lot/Serial Numbers: FBMHDX00436, FBMHDX00352, FBMHDX00455, FBMHDX00384, FBMHDX00434, FBMHDX00443, FBMHDX00407, FBMHDX00363, FBMHDX00424, FBMHDX00442, FBMHDX00321, FBMHDX00387, FBMHDX00339, FBMHDX00448, FBMHDX00383, FBMHDX00437, FBMHDX00362, FBMHDX00394, FBMHDX00397, FBMHDX00395, FBMHDX00355, FBMHDX00374, FBMHDX00451, FBMHDX00368, FBMHDX00457, FBMHDX00440, FBMHDX00419, FBMHDX00421, FBMHDX00427, FBMHDX00459, FBMHDX00378, FBMHDX00345, FBMHDX00458, FBMHDX00425, FBMHDX00366, FBMHDX00480, FBMHDX00418, FBMHDX00454, FBMHDX00188, FBMHDX00403, FBMHDX00452, FBMHDX00386, FBMHDX00343, FBMHDX00369, FBMHDX00464, FBMHDX00413, FBMHDX00346, FBMHDX00388, FBMHDX00389, FBMHDX00406, FBMHDX00416, FBMHDX00453, FBMHDX00399, FBMHDX00401, FBMHDX00428, FBMHDX00380, FBMHDX00371, FBMHDX00392, FBMHDX00344, FBMHDX00404, FBMHDX00356, FBMHDX00376, FBMHDX00470, FBMHDX00353, FBMHDX00359, FBMHDX00391, FBMHDX00460, FBMHDX00410, FBMHDX00379, FBMHDX00390, FBMHDX00449, FBMHDX00372, FBMHDX00377, FBMHDX00462, FBMHDX00338, FBMHDX00423, FBMHDX00420, FBMHDX00438, FBMHDX00432, FBMHDX00373, FBMHDX00367, FBMHDX00446, FBMHDX00370, FBMHDX00429
- Units Affected: 84 systems
The hazard
The recall addresses a manufacturing issue involving insufficient sealing of X-ray tubes in the OEC 3D mobile fluoroscopic C-Arm imaging systems. This defect can result in a potential oil leak and loss of fluoroscopic imaging capability.
Context
GovInfoNow's records show GE OEC Medical Systems, Inc has 2 other recalls on record since 2021-06-10. Other recent recalls of similar products include Philips Integris-Allura System Recall (2026-04-28), Philips Azurion System Recall (2026-04-28), and GE Optima XR200amx Mobile Radiography System Recall (2026-06-05).