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 LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.

FDA Recall Z-1096-2013 · Posted 2013-04-11

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeIYN
Date Initiated2013-02-08
Date Terminated2013-11-21
Product Quantity2061

Reason for Recall

GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultraso

Firm Action

Consignees were sent on 2/8/2013 a GE Healthcare " Urgent Medical Device Correction" letter dated February 8, 2013. The letter was addressed to Hospital Administrators / Risk Manager, Biomedical Engineering and Managers of General/Diagnostic Imaging. The letter described the Safety Issue, Safety Instructions, Affected Product details, Product correction and Contact Information. US customer contact number is (1)800-437-1171.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution, USA, including the states of AL, AZ, AR, CA, CO,K CT, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT NE, NV N NJ, NM, NY, NC, ND, OH, OK, PA, RI ,SC, SD, TN, TX, VA, WA, WI and the countries of AUSTRALIA, AUSTRIA, BRAZIL, CANDA, CHILE, CHINA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY INDIA, INDONESIA ITALY JAPAN, KOREA, LATVIA, LEBANON, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA , SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122114LOGIQ S7 EXPERT, LOGIQ S7 PROGE Healthcare · 2012-10-03K111582LOGIQ S8GE Healthcare · 2011-07-26

Official Source

View FDA Recall →

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

↑