FDAHealthJuly 3, 2025

Philips Ultrasound, Inc — BP10-5ec Transducer Probe

⚠️ To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: July 3, 2025

US Nationwide distribution.

What's affected?

Product: BP10-5ec Transducer Probe
Brand: Philips Ultrasound, Inc
Lot code: 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.

Additional details

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.

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 171,322 units.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.