GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications.
This recall has been terminated (originally issued March 12, 2009).
- Company
- Ge Medical Systems, Llc
- Recall Initiated
- March 6, 2008
- Posted
- March 12, 2009
- Terminated
- September 4, 2014
- Recall Number
- Z-1092-2009
- Quantity
- 4
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to recover.
Distribution
Worldwide Distribution -- USA including states of MD, TX, and VA and country of China.
Lot / Code Info
82416120006, 4103323100, 82416120005, and 214324INNOVA2
Root Cause
Software design
Action Taken
On site visits were performed from 3/6/08 - 12/19/08 to update software on all 5 units.
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