Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system

FDA Recall Z-1148-2014 · Posted 2014-03-06

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2011-03-25
Date Terminated2014-03-13
Product Quantity283 (59 US, 224 OUS)

Reason for Recall

When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image, thus the line measurements may be inaccurate.

Firm Action

No consignee letter was sent out. FMI No. 25431 shows where the Field Engineer had to communicate with the hospital (Instead of them sending a letter). GE Healthcare has updated all of the affected Advantage Workstation systems affected by the GSI viewer issue. At this time, deployment of the recall is considered complete. As an effectiveness check, they have tracked all service requests for the field action to completion. These service requests record the repair of the affected units. Exceptions to completion of the service request have been recorded as well. Records of field action completion will be retained per their processes and procedures.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution: US (nationwide): AL, AZ, CA, CT, FL, IL, IN, IA, KY, MD, MA, MI, MS, NV, NH, NJ, NY, PA, WA, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KUWAIT, LATVIA, NEW ZEALAND, POLAND, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWEDEN,, SWITZERLAND, TAIWAN, and UNITED KINGDOM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081105GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)GE Healthcare · 2008-05-09

Official Source

View FDA Recall →

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

↑