Recall Z-0661-2007 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Sonosite, Inc.
MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
| Date | Mar 29, 2007 (initiated Feb 5, 2007) |
| Status | Terminated |
| Reason | Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db. |
| Root cause | Other |
| Action | On 2/5/2007 firm sent by FED-Ex notification letters to firm representatives. Representatives began hand delivery of recall letter to consignees and retrieval of LAP transducer for return delivery to firm. The letter advised customers that the LAP transducer exceeded the limits specified for radio-frequency emissions. The firm also advised that exceeding the limit may cause the LAP transducer to interfere with surrounding equipment that may be susceptible to radiated emissions and cause surrounding equipment to not perform as expected. |
| Quantity | 6 Devices |
| Distribution | Distribution to USA (Tennessee & Ohio), France, Korea, and Germany. |
| FDA record | Open on fda.gov |