Device product
GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
Z-0114-2013
Product summary
- Event
- Event 63027
- Status
- Terminated
- Classification
- Class II
- Quantity
- 199 installed in the US
- Official record key
device-enforcement:Z-0114-2013
Official wording
Reason: It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
Code information: Model number - 5892935G052G
Distribution pattern: Nationwide distribution
Derived failure modes
-
Unknown
It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.