Philips ultrasound transducers recalled for refurbishment beyond useful life

Plain-English summary

Philips Ultrasound, Inc. is recalling 5,230 VL13-5 ultrasound transducer devices (Model Nos. 989605409592, 989605372211, 989605372213) that were refurbished beyond their useful life. Refurbishment beyond design specifications creates a risk that the devices may not function properly or may degrade during clinical use, potentially affecting diagnostic imaging quality.

The recalled transducers were distributed domestically throughout the United States and internationally to more than 40 countries including Australia, Canada, China, Germany, India, Japan, South Korea, United Kingdom, and others. Healthcare facilities and ultrasound service centers should identify affected units using the provided model numbers and serial numbers listed in the FDA recall notice.

Philips Ultrasound, Inc. advises users to stop using the recalled transducers and contact the company for guidance on replacement, repair, or return. Continued use of transducers refurbished beyond their useful life may compromise diagnostic quality and patient safety.

The recalled product

Product

Philips VL13-5 Transducer.

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Equipment

Hazard

• device-degradation
• equipment-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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