Z-0027-2014Class II

P21x/5-1 MHz transducer, Part Number P07698-23

Name: Z-0027-2014 P21x/5-1 MHz transducer, Part Number P07698-23
Creator: SonoSite, Inc.
Published: 2013-09-11
License: https://open.fda.gov/license/

FUJIFILM SonoSite,Inc. / initiated 2013-09-11 / Terminated / root cause: labeling and UDI

FDA source

SonoSite, Inc. began a recall of P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD... on 2013-09-11. FDA classified it as Class II and gives the reason as "FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0027-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-11
Posted: 2013-10-18
Terminated: 2013-12-11
Recalling firm: FUJIFILM SonoSite,Inc.
Product: P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: SonoSite started calling their consignees on September 13, 2013. For customers who could not be reached via phone, a letter Urgent -Medical Device Removal will be sent on September 17, 2013. Affected customers will be offered a replacement transducer (P07698-24) free of charge. Consignees in the U.S. can call 1-877-657-8118, Monday-Friday, 6:00 a.m. - 5:00 p.m. (PST) or send E-mail to [email protected]. Customers outside the US can call 425-951-1200.
Quantity in commerce: 10 units
Distribution: Worldwide Distribution - USA Nationwide in the states of Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia, and in the country Japan and Italy.
Product codes and lots: Serial Number: 03T861; 03T863; 03T865; 03T867; 03T869; 03T85Z; 03T86C; 03T86F; 03T86H; 03T86K.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0027-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0027-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-23	2013-10-17

Product code IYO

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)