GE Medical Systems, LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
GE Medical Systems, LLC
Lot Codes / Batch Numbers
82416120006, 4103323100, 82416120005, and 214324INNOVA2
Products Sold
82416120006, 4103323100, 82416120005, and 214324INNOVA2
GE Medical Systems, LLC is recalling GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The syst due to GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On site visits were performed from 3/6/08 - 12/19/08 to update software on all 5 units.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MD, TX, VA
Page updated: Jan 10, 2026