MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
This recall has been terminated (originally issued March 29, 2007).
- Company
- Sonosite, Inc.
- Recall Initiated
- February 5, 2007
- Posted
- March 29, 2007
- Terminated
- June 1, 2007
- Recall Number
- Z-0661-2007
- Quantity
- 6 Devices
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db.
Distribution
Distribution to USA (Tennessee & Ohio), France, Korea, and Germany.
Lot / Code Info
Serial Numbers: 037XT6, 0379P5, 037WMJ, 0379P1, 0379P2, 0379P0 Part Number: P05507-10
Root Cause
Other
Action Taken
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.