—#78879

Product

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 product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K023178, K042053
Affected lot / code info: 757398INNOVA

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated: 2008-03-06
Posted by FDA: 2009-03-12
Terminated: 2014-09-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #78879. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.