# FDA recall Z-1757-2024

> **Philips Ultrasound, Inc.** · Class II · device recall initiated 2024-03-23.

## 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.

## Reason for recall

Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns

## Distribution

Worldwide - US Nationwide distribution including in the states of CA, CO, CT, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, NC, NH, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA and the countries of Australia, Austria, Bahrain, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Lithuania, Netherlands, New Zealand, Oman, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United Arab Emirates.

## Key facts

- **Recall number:** Z-1757-2024
- **Recalling firm:** Philips Ultrasound, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-23
- **Report date:** 2024-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bothell, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1757-2024

## Citation

> AI Analytics. FDA recall Z-1757-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1757-2024. Source: US FDA. Licensed CC0.

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