GE OEC Injection Cable Recall for Potential Erroneous Contrast Injection
GE OEC Medical Systems is recalling OEC Injection Cables due to a potential for erroneous auto-injection of contrast dye.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a medical device with a risk of erroneous contrast injection, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling 149 units of the OEC Injection Cable for MedRad Provis V Contrast Injector. The affected cables, which provide a signal to the auto-injector to trigger contrast injection in certain fluoroscope X-ray modes, were distributed nationwide.
The recall was initiated due to a potential for erroneous auto-injection of contrast dye. The source text does not specify the exact technical cause of the error or report any specific injuries or illnesses associated with the defect.
Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Consumers and medical staff should stop using the affected cables and contact the manufacturer for further instructions on the correction to the instructions and use.
The recalled product
- Product
- GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 149
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)
- Serial Numbers: 82-1138
- 82-1586
- 82-2089
- 82-2117
- 82-2182
- 82-2214
- 82-2226
- 82-2262
- 82-2264
- 82-2308
- 82-2312
- 82-2314
- 82-2321
- 82-2328
- 82-2380
- 82-2391
- 82-2438
- 82-2483
- 82-2512
- 82-2516
Distribution
Distributed nationwide across the United States.
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