Z-2654-2010

Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The...

Name: Z-2654-2010 Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The...
Creator: Sonosite, Inc.
Published: 2007-11-02
License: https://open.fda.gov/license/

FUJIFILM SonoSite,Inc. / initiated 2007-11-02 / Terminated / root cause: manufacturing process

FDA source

Sonosite, Inc. began a recall of Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The LAP Transducer label is labeled in part... on 2007-11-02. The reason FDA records is "Sterilization of the SonoSite LAP surgical Transducer with the Sterrad NX System may result in damage to the transducer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2654-2010
Status: Terminated
Initiated: 2007-11-02
Posted: 2010-10-01
Terminated: 2010-10-05
Recalling firm: FUJIFILM SonoSite,Inc.
Product: Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The LAP Transducer label is labeled in part: "MicroMaxx LAP...Manufactured for SonoSite, Inc., Bothell, WA 98021".
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Sterilization of the SonoSite LAP surgical Transducer with the Sterrad NX System may result in damage to the transducer.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On November 2, 2007, SonoSite sent out the Important Information Regarding Sterrad NX Incompatibility letter and the Technical Bulletin 005/07 Rev A to their consignees. The letter advises the consignees that SonoSite has recently found that sterilization of the SonoSite SLT and LAP surgical ultrasound transducers with the Sterrad NX system may result in damage to the transducer. The Technical Bulletin 005/07 Rev B dated November 2, 2007 informs the consignees that the damage has been observed primarily on the circuit board in the transducer connector, and cable and laparoscope damage may also be occurring. All damages have occurred after processing using the Sterrad NX systems in its "Advanced" cycle and the potential damage from the use of "normal" cycle is being evaluated by the firm. Consignees should call the Technical Support at 1-425-951-1330 or 1-877-657-8118 or e-mail to [email protected] for any questions regarding the recall.
Quantity in commerce: 16 units
Distribution: Devices were distributed to medical centers and hospitals in AR, CA, IN, KS, MA, MD, MI, NC, NE, NJ, NV, OH, SC, TN, TX, WI, Washington DC and to FOREIGN COUNTRIES Australia, China, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Korea, Republic of, Libyan Arab Jamahiriya, Mexico, Spain, United Arab Emirates, United Kingdom, and United States.
Product codes and lots: 16 devices are identified with Serial Numbers: 038VWM, 038FK1, 0379P6, 038G67, 038VWK, 038192, 0379P1, 0379P2, 038FJZ, 038FJW, 0379P0, 0379P5, 037WMJ, 038VWP, 037XT6, and 038153.

Product code IYN

K043559Class IISonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. / cleared 2005-01-12

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)