Recall Z-0706-2025— GE OEC Medical Systems, Inc
Class II · Ongoing
Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2024-11-21. It names 3 FDA 510(k) clearances: K132027, K111551, K021049. Product: OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.. Reason: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability..
- Recalling firm
- GE OEC Medical Systems, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-21
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
3 on FDA's record- K132027 — OEC 9800 PLUS
- K111551 — OEC(R) 9800, OEC(R) 9800 PLUS
- K021049 — OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
Reason for recall
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Data sourced from openFDA. This site is unofficial and independent of the FDA.