Recall
FDAHealthSeptember 5, 2025

Philips Ultrasound, Inc — Philips S5-2 Ultrasound Transducer

⚠️ 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
September 5, 2025

US Nationwide distribution.

What's affected?

Product
Philips S5-2 Ultrasound Transducer
Lot code
Model No. 989605368393; (01)00884838064638(21)B0C824; Serial No. B0C824.

Additional details

Model No. 989605368393; (01)00884838064638(21)B0C824; Serial No. B0C824.

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 1 unit.

View original FDA notice →

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