OEC 3D Mobile Fluoroscopic X-Ray System Tube Sealing Defect Recall
GE OEC Medical Systems is recalling 84 OEC 3D mobile fluoroscopic X-ray systems due to manufacturing defects in X-ray tube sealing that can cause oil leaks and loss of imaging capability.
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: This is an FDA Class II device recall with a manufacturing defect affecting a critical-use medical device (surgical imaging system). Although no illnesses or injuries have been reported, the potential for imaging loss during surgical procedures and oil leaks presents a risk of harm in a professional medical setting.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling 84 OEC 3D REF mobile fluoroscopic X-ray systems due to a manufacturing issue involving insufficient sealing of the X-ray tubes.
The systems are used to provide fluoroscopic images and volumetric reconstructions during diagnostic, interventional, and surgical procedures. The manufacturing defect can result in oil leaks and potential loss of fluoroscopic imaging capability, which could compromise the device's ability to provide real-time imaging guidance during these procedures.
The recalled systems were distributed throughout the United States (including Alaska, Hawaii, and Guam) and internationally to Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and the United Kingdom.
Healthcare facilities and physicians using affected systems should contact GE OEC Medical Systems, Inc. for instructions regarding remediation options.
The recalled product
- Product
- OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions durin
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- oil-leak
- imaging-failure
Distribution
Distributed in 44 states:
- AK
- AZ
- CA
- CO
- CT
- DC
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MD
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NJ
- NM
- NV
- NY
- OH
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
- WY
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