Summary
The FDA issued a Class III for BP10-5ec Transducer Probe by Philips Ultrasound, Inc. Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field..
Details
Source
Device Recall
External ID
Z-2349-2025
Action Date
2025-09-03
Status
Ongoing
Category
device
Product Description
BP10-5ec Transducer Probe
Lot/Code Info: Model No. 989605395642; UDI: (01)00884838061552(21)B29VPV, (01)00884838061552(21)B29VQ6, (01)00884838061552(21)B2CYJ4, (01)00884838061552(21)F06M63, (01)00884838061552(21)F06QYR, (01)00884838061552(21)B2CY7P, (01)00884838061552(21)F058R4, (01)00884838061552(21)B2CY8T, (01)00884838061552(21)F05YF6, (01)00884838061552(21)F0628C, (01)00884838061552(21)B29VPW, (01)00884838061552(21)F064N9, (01)00884838061552(21)F078HF, (01)00884838061552(21)F05Y6Y, (01)00884838061552(21)B2CYJJ, (01)00884838061552(21)B2CYD7; Serial No. B29VPV, B29VQ6, B2CYJ4, F06M63, F06QYR, B2CY7P, F058R4, B2CY8T, F05YF6, F0628C, B29VPW, F064N9, F078HF, F05Y6Y, B2CYJJ, B2CYD7.
Quantity Affected: 171,322 units
Reason for Recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-03
Company
Reedsville, PA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips Ultrasound, Inc has 111 FDA actions in our database, including 111 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Ultrasound, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Ultrasound, Inc have FDA actions?
Philips Ultrasound, Inc has 111 FDA actions in our database, including 111 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2349-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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