GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a

FDA device recall Z-0474-2009 · posted 2009-01-21 · Terminated

Recall details

Recalling firm

GE Medical Systems, LLC

Reason for recall

Software error, computer: GE Healthcare has became aware of an issue with Error Management affecting the Innova 2100, 3100/3100 IQ & 4100/4100IQ. It was reported that when the foot switch was pressed, the live monitor screen was blank and it looked like there were no X-rays being emitted. But the message "Acquisition in progress" was displayed on the DL monitor, even after the foot switch was r

Action taken

Consignees sent a "GE Urgent Medical Device Correction" letter dated February 28, 2008. The letter was addressed to Hospital Administrators/Hospital Risk Management Department/Managers of Radiology-Cardiology/ Radiologists-Cardiologists. The letter described the affected products, safety Issue, short term recommendations, long term solution and contact Information. The first batch of letters was received by customers on 5/28/08. For further information, please contact GE Healthcare at 262-544-3894

Root cause

Software design

Status

Terminated

Product code

MQB

Quantity affected

397

Distribution

USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL IN, KS, KY, LA, ME, MD, MA, MI,MN, MS,MO, MT, NE, NV, NH, NJ, NM, NY,NC, ND, OH, OK OR, PA, RI, SC, SD, TN, TX UT,VT, VA, WA,

Date initiated

2008-01-30

Date posted

2009-01-21

Date terminated

2016-03-07

Location

Waukesha, WI

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