Philips Ultrasound, Inc recalls Philips X3-1 Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Philips X3-1 Ultrasound Transducer

An URGENT Medical Device Correction Notice, dated 8/19/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377.

• FDA enforcement recordOfficial FDA database entry for Z-1627-2026
• FDA 510(k) clearance · K042540The device's official FDA premarket clearance record
• FDA device classification · ITXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1570The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Philips Ultrasound, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.