The Recall Desk
HighFDA (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.

What this means for you

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
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:

Related recalls

Same manufacturer · Philips Ultrasound, Inc.

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