Agency classClass IIOur severity:High FDA (Devices)·Z-1757-2024·Announced 2024-05-15

Philips 5000 Compact Series Ultrasound Systems pose uncontrolled burn risk

Philips 5000 Compact Series ultrasound systems may leave unselected transesophageal transducers powered without temperature monitoring, risking patient burns during imaging procedures.

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: This FDA Class II recall addresses a risk-of-harm product where unselected transducers may remain powered without temperature monitoring or control, creating burn injury risk. No reported injuries or deaths are documented, fitting the rubric criterion for 'High' severity.

Plain-English summary

Philips Ultrasound, Inc. is recalling 363 units of the 5000 Compact Series Ultrasound Systems across multiple product models. The systems have a documented hazard: when a transesophageal echocardiography (TEE) transducer is connected but not selected for imaging, and the user performs non-TEE imaging and then removes the selected transducer, the unselected TEE transducer may remain powered. This unselected transducer lacks temperature monitoring and control, which may allow it to reach temperatures above safe limits and potentially cause burns to the patient.

The affected systems were manufactured on or before December 20, 2023, and purchased with Deluxe or Premium Cart options. The systems have been distributed worldwide, including throughout the United States and to numerous countries in Europe, Asia, Australia, the Middle East, Africa, and South America.

The specific product models involved are the 5500 CV, 5500 P, 5500 W, 5500 G, 5300 W, 5300 P, and 5300 G. Multiple affected serial numbers have been documented by the FDA. No reported injuries or deaths have been documented at this time, but the thermal hazard poses a risk to patients undergoing ultrasound imaging with affected equipment.

The recalled product

Product: 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come with multiport adapters.
Manufacturer: Philips Ultrasound, Inc.
Category: Medical Device — Diagnostic Ultrasound
Hazard: burn-injury
temperature-control-failure
Affected units: 363

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)

USN23P0623
USN23P0624
USN23P0685
USN23P0720
USN23P0615
USN23P0627
USN23P0611
USN23P0683
USN23P0682
USN23P0625
USN23P0173
USN23P0164
US823P0231
USN23P0613
USN23P0172
USN23P0721
USN23P0410
USN23P0612
USN23P0614
USN23P0171

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Same manufacturer · Philips Ultrasound, Inc.

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