Z-0661-2007

MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer

Name: Z-0661-2007 MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
Creator: Sonosite, Inc.
Published: 2007-02-05
License: https://open.fda.gov/license/

FUJIFILM SonoSite,Inc. / initiated 2007-02-05 / Terminated

FDA source

Sonosite, Inc. began a recall of MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer on 2007-02-05. The reason FDA records is "Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0661-2007
Status: Terminated
Initiated: 2007-02-05
Posted: 2007-03-29
Terminated: 2007-06-01
Recalling firm: FUJIFILM SonoSite,Inc.
Product: MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db.
FDA 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 in commerce: 6 Devices
Distribution: Distribution to USA (Tennessee & Ohio), France, Korea, and Germany.
Product codes and lots: Serial Numbers: 037XT6, 0379P5, 037WMJ, 0379P1, 0379P2, 0379P0 Part Number: P05507-10

Product code IYN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)