OEC 9800 Fluoroscopy Systems Image Intensifier May Detach and Fall
The image intensifier on GE OEC 9800 fluoroscopy systems can detach and fall if the system experiences a large impact force during movement. This could result in injuries including fractures, bruising, and contusion.
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 medical device recall for a product that poses a risk of serious injury (fractures, contusions, hematoma) if the image intensifier detaches and falls. No injuries have been reported. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
GE OEC Medical Systems, Inc. is recalling 58 OEC 9800 Systems with 9-inch Image Intensifiers. These systems are used in medical facilities to provide fluoroscopic and digital spot imaging.
The image intensifiers can become detached if the systems encounter a large impact force when being moved or transported. A falling image intensifier could cause injuries to personnel or bystanders, including fractures, hematoma, contusion, bruises, or pain.
The recalled systems have been distributed worldwide, with extensive distribution across the United States and internationally to numerous countries. Affected healthcare facilities should contact GE OEC Medical Systems, Inc. for guidance regarding their systems.
The recalled product
- Product
- OEC 9800 Systems with 9-inch Image Intensifier
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- device-detachment
- falling-object
- impact-injury
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 (20)
- UDI-DI: 00840682114349. Serial Numbers: 89-0317
- 89-0554
- 8S-1293
- 8S-0509
- 8S-0108
- 8S-1029
- 8S-2836
- 89-3028
- 8S-1574
- 89-0609-RC
- 89-1308
- 8S-0394
- 89-0979
- 8SXXXX03626
- 8SXXXX03683
- 8SXXXX03681
- 8S-1894
- 8S-0175
- 8S-2988
- 89-2459
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27