PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Enterprise 1.5T

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Enterprise 1.5T, Model Number: 781145;

Philips originally notified consignees on 03/24/2025 with Updated URGENT Medical Device Correction letter. It was noted that it contained incorrect information and on 04/09/2025 Philips sent an updated Updated URGENT Medical Device Correction letter. Consignees were instructed to take the following actions prior to a patient scan: 1. Inspect the QBC seal for separation between the cone cover and QBC cover. 2. If QBC seal is found detached or loose, Stop-use immediately. 3. Contact your local Philips service representative. If QBC seal becomes loose during a patient scan: 1. Immediately stop scanning and carefully remove patient from the system. 2. Contact your local Philips service representative. Consignees were also instructed to circulate this URGENT Medical Device Correction letter to all users of this device so that they are aware of the issue, retain this letter with your system(s) until a solution is installed on your system, ensure the letter is in a place likely to be seen/viewed, and complete and return the included response form to Philips promptly and no later than 30 days from receipt via email to: philips.recall@philips.com.

• FDA enforcement recordOfficial FDA database entry for Z-1770-2025
• FDA 510(k) clearance · K193215The device's official FDA premarket clearance record
• FDA 510(k) clearance · K213516The device's official FDA premarket clearance record
• FDA device classification · LNHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1000The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Search 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.