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

FDA device recall Z-0691-2008 · posted 2008-01-31 · Terminated

Recall details

Recalling firm

GE Healthcare

Reason for recall

Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In such cases, the system continued to send out X-rays without reporting an error message. The result was that the live imaging screen displayed an older "frozen" image until the operator released the

Action taken

Customers were contacted by means of an Urgent Medical Device Correction Letter on November 9, 2007. The letter described the product and the safety issue. The letter also made short term recommendations and described a long term solution, which is pending as an expected hardware and/or software modification that will be made at no cost. Short Term Recommendation: Take extra care when working with motionless anatomy or devices where there is little evident motion to warn you of the frozen image occurrence. Always completely shut down and restart the system (not just reset) immediately after such an error occurs. Also, please immediately report this issue to your local GE Healthcare field service engineer.

Root cause

Device Design

Status

Terminated

Product code

MQB

Quantity affected

320

Distribution

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

Date initiated

2007-11-15

Date posted

2008-01-31

Date terminated

2016-01-29

Location

Waukesha, WI

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