Terminated

Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878.

FDA Recall Z-2312-2008 · Posted 2008-09-20

Recalling FirmGE Healthcare

Recall StatusTerminated

Product CodeLLZ

Date Initiated2008-05-01

Date Terminated2011-12-11

Product Quantity5,249 (2,104 US/ 3,145 OUS)

Reason for Recall

GE Healthcare has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety.

Firm Action

Consignees were sent a GE "Urgent Field Safety Notice" letter dated March 13, 2008 addressed to Hospital Administrators; Managers of Radiology/Cardiology; Radiologists/Cardiologists on May 2008. The letter described the safety issue, affected product, product correction, safety instructions and contact information. A GE Field Engineer to visit site to implement the correction (FMI No. 25409). Contact information: 800-437-1171 (USA); 0120-055-919 (Japan); 0800-15-25-25 (France); for all other countries contact your local GE Healthcare sales or field representative.

Root Cause

Software design

Distribution Pattern

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Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041521VOLUME VIEWER PLUSGeneral Electric Medical Systems · 2004-06-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.