Philips L12-5 Transducer Probe Recalled to Clarify Useful Life Labeling

Plain-English summary

Philips Ultrasound, Inc is recalling 171,322 units of the L12-5 38mm Transducer Probe (Model No. 989605428532) to provide clarification and labeling that defines the useful life of these ultrasound transducers. The recall was initiated to ensure adequate information is available regarding proper device usage in the field.

The affected transducers were distributed nationwide throughout the United States. The recall affects specific serial numbers and UDI codes, including B305XD, F05R7X, B1Y35V, B305ZX, F05K8W, B3GWRJ, B1Y306, B1Y3CG, B1Q699, B1Y3C4, B1RXWK, B305X5, B305ZK, B3NFD5, and F034C6.

Healthcare providers and facilities using these transducers should contact Philips Ultrasound, Inc for updated labeling information that clarifies the useful life of the device. Users should verify their devices against the affected serial numbers and review the clarified labeling materials.

The recalled product

Product

L12-5 38mm Transducer Probe

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound transducer

Hazard

• inadequate-labeling

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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