Agency classClass IIOur severity:High FDA (Devices)·Z-2517-2023·Announced 2023-09-13

Philips 3D9-3v Ultrasound Transducer may separate due to bonding defect

Philips 3D9-3v Transducer units may separate at the chassis bonding, risking electric shock and tissue damage if safety systems fail. Affected units distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a medical device with potential for serious patient harm (electric shock and tissue damage). No injuries have been reported. This matches the rubric criterion for score 3: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

The Philips 3D9-3v Transducer is an accessory to multiple Philips ultrasound systems, including the EPIQ Elite, Affiniti 30, 50, and 70, ClearVue 850, HD15, iU22, and Compact 5000. The transducer consists of two bonded parts.

A manufacturing defect in the chassis bonding may cause these two parts to separate. If separation occurs, users and patients could face risk of tissue damage and electric shock, particularly if the device's built-in electrical safety measures were to also fail.

A total of 449 affected transducers have been distributed worldwide, including across U.S. states and multiple countries. The recalled units can be identified by their serial numbers, which are listed with the UDI-DI 00884838061545. Customers with affected units should verify their device serial number and contact Philips Ultrasound, Inc. for instructions regarding replacement or repair.

The recalled product

Product: 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Manufacturer: Philips Ultrasound, Inc.
Category: Medical Device — Ultrasound Transducer
Hazard: component-separation
electric-shock
tissue-damage
Affected units: 449

Is your product affected?

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

Lot numbers (20)

UDI-DI:00884838061545
Serial Numbers: F07VBZ
F083JP
F086Z5
F088QC
F08JPF
F08K4H
F08VLP
F08VLY
F08W1C
F08W1D
F08W1J
F08W1K
F08W1L
F08W1M
F08W1Q
F08WXP
F08WXY
F08WZY
F08X01

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Same manufacturer · Philips Ultrasound, Inc.

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Same hazard · component separation