PHILIPS MEDICAL SYSTEMS recalls Philips Spectral CT on Rails. Model Number: 728334.

Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.

Philips Medical notified consignees on about 03/07/2026 via letter. Consignees were instructed to identify any affected systems in inventory and specifically for each issue: 1. Issue #1: Ensure to follow the instructions mentioned in the IFU Section 4 Preparing for an Examination and Sub section Gantry Operation. 2. Issue #2: Avoid the Select Previous Surview Unavailable issue, manually remove the patient's middle name while importing the patient detail from HIS/RIS. 3. Issue #3: if Define Head Area option is grayed out with DoseRight Index (DRI) on, review the dose levels displayed on the User Interface, confirm and adjust the dose settings to appropriate levels before executing the scan as instructed in the IFU. Consignees were also instructed to complete and return the response form, to circulate the Urgent Medical Device Correction Letter to all users of the affected device so that they are aware of the issues, and retain the letter with affected system(s) until a solution is installed on each system; ensure the letter is in a place likely to be seen/viewed. Philips will contact each consignee to schedule a time for a Philips Field Service Engineer (FSE) to visit each site and install the solution to resolve the issues (reference FCO72800830).

• FDA enforcement recordOfficial FDA database entry for Z-1825-2026
• FDA 510(k) clearance · K212875The device's official FDA premarket clearance record
• FDA device classification · JAKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1750The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find PHILIPS MEDICAL SYSTEMSSearch 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.