FDA Medical Device Recalls (openFDA)
Sonosite, Inc.: MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
- Recall number
- Z-0661-2007
- Recalling firm
- Sonosite, Inc.
- Product
- MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
- Status
- Terminated
- Initiated
- 2007-02-05
- Posted
- 2007-03-29
- Terminated
- 2007-06-01
- 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.
- Lot, serial or model codes
- Serial Numbers: 037XT6, 0379P5, 037WMJ, 0379P1, 0379P2, 0379P0 Part Number: P05507-10
- 510(k) numbers
- ["K043559","K053069"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3002087856
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28