GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6 ,5.0.7, 5.0.8 and 4.1. The CIC Pro" Clinical Information Center Ce

FDA device recall Z-1232-2009 · posted 2009-05-04 · Terminated

Recall details

Recalling firm

GE Medical Systems Information Tecnology

Reason for recall

GE Healthcare is aware of potential network time issues associated with the time change aspects of certain CARESCAPE CIC Pro" software versions. These issues may impact patient safety. No reported patient injuries or illnesses for the use of this device in conjunction with this device correction.

Action taken

Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated February 27, 2009. The letter was addressed to the Chief of Nursing/Chief of Biomedical Engineering and Risk Manager/Healthcare Administrator. The letter describes the Safety Issue, Affected Product Details, Safety instructions, Product Correction, and Contact Information. Direct questions to your local GE Healthcare Field Service Representative or the GE Healthcare Technologies Support Center by calling 1-800-558-7044 (Option 2, Technical Support).

Root cause

Software design

Status

Terminated

Product code

DSI

Quantity affected

12,737

Distribution

Worldwide Distribution including US (states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, PR, OK, OR, PA, R

Date initiated

2009-02-27

Date posted

2009-05-04

Date terminated

2014-09-15

Location

Wauwatosa, WI

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