Image intensifier detachment hazard in OEC fluoroscopy imaging systems
GE OEC field upgrade kits for fluoroscopy systems may have image intensifiers that detach during movement, potentially falling and causing injuries.
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 for a risk-of-harm medical device component that may detach and cause injury. No hospitalizations or injuries have been reported to date.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling Field Upgrade Kits with part numbers 5451208, 5485304, and 5761613 used with OEC Flexiview 8800, OEC 9800, and OEC 9900 medical imaging systems. These kits have been distributed worldwide, including throughout the United States.
The image intensifiers in these systems provide fluoroscopic and digital spot images. These components may become detached if the systems encounter large impact forces when moved. If the image intensifier detaches and falls, it could strike nearby personnel and cause injuries, potentially including fractures, hematomas, contusions, bruises, or pain.
The recalled product
- Product
- Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems
- Manufacturer
- GE OEC Medical Systems, Inc
- Category
- Medical Device — Imaging Systems
- Hazard
- equipment-detachment
- fall-hazard
- crush-injury
- fracture-risk
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)
- P/N/Sales Order Number: 5451208/80165102
- 80171955
- 80173514
- 80162453
- 80183950
- 80151733
- 80163547
- 80171532
- 80156410
- 80176650
- 10530514
- 105449333
- 80167595
- 5485304/10557644
- 118687327
- 5761613/10283014
- 10152211
- 105108003
- 105114645. OEC 9800
- UDI-DI: 00840682114349
Distribution
Distributed nationwide across the United States.
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