CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system

Potential for units suspended on the ceiling to fail and fall.

The firm distributed recall notifications dated 8/31/2023 via FedEx to affected consignees. Consignees are instructed to immediately stop use of affected devices and contact their local Philips service representative if the Ceiling Suspension becomes unstable, if moving the Ceiling Suspended X-Ray Tube requires a high amount of force, or if moving the Ceiling Suspended X-Ray Tube is noticeably hampered. The recall notice is to be circulated among all device users, so they are aware of this issue and placed as an addendum in the IFU. Consignees are to complete the provided response form and return it to Philips no later than 30 days from notification receipt via email to [email protected]. Philips will contact consignees to schedule a time for a Field Service Engineer to visit customer sites to inspect affected systems and correct the issue. Consignees with any questions are to contact the Customer Care Solutions Center at 1-800-722-9377.