Recall Z-1096-2013 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Healthcare, LLC
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.
| Date | Apr 11, 2013 (initiated Feb 8, 2013) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| 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. |
| Quantity | 2061 |
| Distribution | 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, CR |
| FDA record | Open on fda.gov |