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Terminated

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.

FDA Recall Z-1093-2009 · Posted 2009-03-12

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeMQB
Date Initiated2008-03-06
Date Terminated2014-09-04
Product Quantity1

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.

Firm Action

On site visits were performed from 3/6/08 - 12/19/08 to update software on all 5 units.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution -- USA including states of MD, TX, and VA and country of China.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042053INNOVA 4100, INNOVA 3100Ge Medical Systems, Inc. · 2004-08-26K023178INNOVA 4100Ge Medical Systems, Inc. · 2002-11-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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