Philips Ultrasound Transducers Recalled After Over-Refurbishment

Plain-English summary

Philips Ultrasound, Inc is recalling 5,230 units of the Philips 3D9-3v Transducer. The devices were refurbished beyond their useful life, which may compromise their safety and performance during medical procedures.

The recall affects Model Nos. 989605395622, 989605415032, 989605440832, 989605440831, and 989605325181, along with numerous unit-specific identifiers listed in the recall notice. The devices were distributed nationwide in the U.S. and internationally to multiple countries.

Healthcare facilities and users should immediately stop using the affected transducers and contact Philips Ultrasound, Inc for replacement or repair. The firm is notifying distributors and customers directly and will arrange for return or replacement of the recalled units.

This recall was classified by the FDA as Class II, indicating a potential risk of temporary or medically reversible adverse health consequences if the device fails during use.

The recalled product

Product

Philips 3D9-3v Transducer.

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Transducer

Hazard

• device-failure
• over-refurbishment

Affected units

5,230

Is your product affected?

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

Distribution

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