FDA Medical Device Recalls (openFDA)
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 number
- Z-1092-2009
- Recalling firm
- GE Medical Systems, LLC
- 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.
- Status
- Terminated
- Initiated
- 2008-03-06
- Posted
- 2009-03-12
- Terminated
- 2014-09-04
- Reason
- 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.
- Root cause
- Software design
- Action
- On site visits were performed from 3/6/08 - 12/19/08 to update software on all 5 units.
- Quantity
- 4
- Distribution
- Worldwide Distribution -- USA including states of MD, TX, and VA and country of China.
- Lot, serial or model codes
- 82416120006, 4103323100, 82416120005, and 214324INNOVA2
- 510(k) numbers
- ["K031637","K042053"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28