GE Innova 3100 / 3100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188. The product is indicated for

FDA device recall Z-1475-2009 · posted 2009-06-19 · Terminated

Recall details

Recalling firm

GE Medical Systems, LLC

Reason for recall

GE Healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on Innova single plane cardiovascular X-ray imaging systems while using the image auto-archiving function. when occurring during X-Ray imaging, the acquisition fails and the user has to rest the system. To date, one patient death has been reported related to this issue.

Action taken

GE Healthcare sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Health Care Professionals describing the problem with the affected devices including instructions to avoid further problems until a GE Healthcare service representative is able to make contact and upgrade the system. Further questions may be addressed by calling 1-800-437-1171.

Root cause

Process control

Status

Terminated

Product code

MQB

Quantity affected

524 plus 11 either 3100 or 4100

Distribution

Worldwide Distribution - US including Puerto Rico and 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, O

Date initiated

2008-06-17

Date posted

2009-06-19

Date terminated

2014-10-22

Location

Waukesha, WI

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