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, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.

FDA Recall Z-1747-2010 · Posted 2010-06-02

Recalling FirmGe Healthcare, Llc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2010-02-09
Date Terminated2011-12-18
Product Quantity73 devices

Reason for Recall

GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. When using the Print Image or Print Screen feature on SenoAdvantage 2.2, the Scale factor annotation printed on hard copy images is inaccurate. Secondary Capture (SCPT) images displayed on the screen and Secondary Capture hard copy images may a

Firm Action

The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated February 8, 2010 to customers. The letter described the Safety Issue, Affected product details, Safety Instructions to prevent further inaccurate scale factor annotation, Product Correction and Contact Information. GE Healthcare will correct all affected workstations by providing a software upgrade and an updated Operator Manual. The GE service representative will contact customer to arrange for this correction. If you have any questions or concerns regarding this notification, 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

Distribution Pattern

Worldwide distribution: USA including states of CA, FL, GA, MD, NJ, NM, NY, NC, OK, TX and countries of THAILAND, TAIWAN, SWEDEN SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, PAKISTAN, MEXICO, JAPAN, ITALY,GREECE, FRANCE, COLOMBIA, CHILE, CANADA, BELGIUM, and BAHRAIN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

↑