The FDA announced on March 23, 2024, that Philips Ultrasound, Inc. is recalling 5000 Compact Series Ultrasound Systems due to a risk of patient burns. The hazard involves the transesophageal echocardiography transducer potentially exceeding temperature limits without proper monitoring or control.
How to tell if you have it
- Brand: Philips
- Product: 5000 Compact Series Ultrasound Systems
- Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, 5300 W/795146, 5300 P/795147, 5300 G/795148
- Manufactured on or before 20-Dec-2023
- Purchased with Deluxe and Premium Cart options
- Units affected: 363
The hazard
The ultrasound system may have power but no temperature monitoring or control for the transesophageal echocardiography transducer, which can result in temperatures above the limit and cause patient burns. This occurs when the TEE is connected but not selected, when non-TEE imaging continues, or when a selected imaging transducer is removed.
Context
GovInfoNow's records show Philips Ultrasound, Inc. has issued 14 other recalls since April 29, 2019. Recent brand recalls include the Philips L17-5 Ultrasound Transducer Recall on Sept. 5, 2025, and the Philips S7-2t Transducer Probe Recall on July 3, 2025, both addressing useful life labeling clarifications. Other recent recalls of similar products include the Philips Brilliance CT 64 Medical Scanner Recall (Aug. 7, 2026) for unintended radiation risk and the Lutronic DermaV Laser System Recall (Aug. 6, 2026) for patient burn risks.