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.
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: 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.
- Hazard
- burn-injury
- temperature-control-failure
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.
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