GE ADVANTAGE SIM MD versions 5.x, 6.x, 7.x up to and including version 7.7.0 Advantage Sim MD is used to prepare geometr

FDA device recall Z-1473-2011 · posted 2011-03-02 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has become aware that inconsistent DRR (Digitally Reconstructed Radiographic) visualization may occur when the blended DRR feature or the Isocenter Move mode feature is used in combination with specified other functions of the AdvantageSim application on Advantage Workstation. These inconsistencies may affect patient safety. Other AdvantageSim functions are not affected.

Action taken

GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 23, 2010. The letter was addressed to Hospital Administrators / Risk mangers, Oncology Department Managers / Radiation Oncologists, & Radiation Physicists / Dosimetrists / Therapists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For any questions or concerns regarding this recall, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 - 055 - 919 For other countries, please contact your local GE Healthcare Service Representative.

Root cause

Software design

Status

Terminated

Product code

KPG

Quantity affected

1531

Distribution

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MA, MI, MN, MS,MO, NT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX

Date initiated

2010-11-24

Date posted

2011-03-02

Date terminated

2012-08-03

Location

Waukesha, WI

Related 510(k) clearances