GE Medical Systems, LLC recalls GE SIGNA PET/MR

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

GE HealthCare issued an URGENT CORRECTION NOTICE to it consignees on 06/20/2025 via traceable means. The notice explained the safety issue and requested the following actions be taken: "You can continue to use your MR system by following the instructions below: In the undocked position, lock the table by pressing the pedal in the front of the table. Check to see that all casters are locked and that the table is secure. Contact your GE HealthCare representative for assistance if any of the casters do not lock. Before each patient transfer verify that the caster locks are engaged. If you notice more than one caster is damaged or fails to lock properly, use particular caution as the table may move while in use. No additional steps are required to continue to use your table in the docked position. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." "GE HealthCare will inspect and if necessary, correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction." " if you have any questions for concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative."

• FDA enforcement recordOfficial FDA database entry for Z-2309-2025
• FDA 510(k) clearance · K142098The device's official FDA premarket clearance record
• FDA 510(k) clearance · K163619The device's official FDA premarket clearance record
• FDA 510(k) clearance · K213709The 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 GE Medical Systems, LLCSearch 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.