CLASS II Device recall · Reported 23 Oct 2013 · FDA Enforcement Report
P21x/5-1 MHz transducer recalled by SonoSite
SonoSite is recalling P21x/5-1 MHz transducer, distributed nationwide in the US. The recall was initiated on 11 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0027-2014
- FDA event ID
- 66346
- Recalling firm
- SonoSite, Bothell, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Sep 2013
- FDA classified
- 17 Oct 2013
- Reported
- 23 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 11 Sep 2013 | Recall initiated by company | |
| 17 Oct 2013 | Classified by FDA | +36 days |
| 23 Oct 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA Nationwide in the states of Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia, and in the country Japan and Italy.
Nationwide FloridaGeorgiaOklahomaPennsylvaniaTennesseeTexasVirginiaWest Virginia
Questions about this recall
Is P21x/5-1 MHz transducer recalled?
Yes. SonoSite recalled P21x/5-1 MHz transducer on 11 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0027-2014.
Why was it recalled?
FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.
Which lots are affected?
Serial Number: 03T861; 03T863; 03T865; 03T867; 03T869; 03T85Z; 03T86C; 03T86F; 03T86H; 03T86K.
Where was it sold?
Worldwide Distribution - USA Nationwide in the states of Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia, and in the country Japan and Italy.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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