Innova 4100 / 4100 IQ, 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-1093-2009
Quantity: 1
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.