Philips Ultrasound, Inc recalls Philips C5-1 Transducer.

Ultrasound transducer devices were refurbished beyond their useful life.

Philips C5-1 Transducer.

An URGENT Medical Device Recall notification dated 5/28/25 was mailed to consignees. The notification informs consignees that Philips Ultrasound will be replacing transducers that were refurbished beyond their useful life with a new transducer. Consignees may continue to use affected devices while awaiting replacement; consignees should use devices in accordance with their intended use and per the instructions provided int he User Manual. Users should perform visual inspection and electrical safety testing as indicated in the User Manual; if a device does not pass inspection, it should be removed from clinical use. Consignees are asked to return the completed Response Form and circulate the provided notification to all users to ensure awareness. A copy of the recall notification should be kept with affected transducers until their replacement. Consignees with any questions can contact the Customer Care Solutions Center at 1-800-722-9377. Additional consignees were identified and notified via URGENT Medical Device Recall Notification on 9/5/25.

• FDA enforcement recordOfficial FDA database entry for Z-2049-2025
• FDA 510(k) clearance · K091804The device's official FDA premarket clearance record
• FDA 510(k) clearance · K111513The device's official FDA premarket clearance record
• FDA 510(k) clearance · K123754The device's official FDA premarket clearance record
• FDA 510(k) clearance · K130499The device's official FDA premarket clearance record
• FDA 510(k) clearance · K132304The 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.