GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available

The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install.

GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 07/12/2024 by letter using a traceable means. The notice explained the issue and requested the following actions to be taken by the consumer/user: "You may continue to use the Proteus XR/a as intended for clinical use. This issue has no effect on clinical use of the equipment. If you intend to de-install your Proteus XR/a system or contract a 3rd party to de-install the system: 1. Ensure all instructions and guidance in the De-Installation Manual are followed. 2. Access the De-installation Manual from the product documentation portal: https://www.gehealthcare.com/support/manuals In the search bar, type either: Proteus XR/a De-Installation Manual or 5273026-8EN 3. If the table dolly service tool (Part Number: 611-3700) that is used during the original system installation has been retained, ensure the bolts specified in Section 1.4.1 the De-installation Manual are used with the table dolly during de-installation and the instruction for use in Section 1.4.2 of the De-installation Manual is followed. 4. If you do not have this table dolly, follow Section 1.4.3 of the De-installation Manual for de-installation of the table without the dolly. Please ensure all potential service users in your facility or those contracted by your facility are made aware of this notification and the recommended actions." For questions: contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.