SonoSite P21x/5-1 Transducer Recalled for Biopsy Bracket Sensor Defect
SonoSite, Inc. is recalling 10 P21x/5-1 MHz transducers because the Biopsy Bracket Sensor is not working as intended.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
SonoSite, Inc. is recalling 10 units of the P21x/5-1 MHz transducer, Part Number P07698-23. The recall was initiated because the firm discovered that the Biopsy Bracket Sensor is not working as intended.
The affected devices are distributed worldwide, including in the United States (Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas, and West Virginia) and in Japan and Italy. The specific serial numbers for the recalled units are 03T861, 03T863, 03T865, 03T867, 03T869, 03T85Z, 03T86C, 03T86F, 03T86H, and 03T86K.
Healthcare providers and consumers should check their inventory for these specific serial numbers. If a device is found, it should be removed from service and returned to SonoSite, Inc. according to the firm's instructions.
The recalled product
- 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…
- Manufacturer
- SonoSite, Inc.
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Serial Number: 03T861
- 03T863
- 03T865
- 03T867
- 03T869
- 03T85Z
- 03T86C
- 03T86F
- 03T86H
- 03T86K.
Distribution
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