GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier E
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled 18,411 magnetic resonance imaging (MRI) systems worldwide, including models SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, and 1.5T SIGNA Cre. The systems were distributed across the United States, Puerto Rico, the U.S. Virgin Islands, and numerous countries internationally. The recall addresses a hazard that can occur during magnet de-installation: if rigging and hardware used to attach and transport the magnet are not properly installed and secured, the magnet may fall and cause injury.
The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
Reason for recall: During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury. Distribution: Worldwide Distribution: US (nationwide), including Puerto Rico and the U.S. Virgin Islands; and OUS (Foreign) was made to Albania, Algeria, Argentina, Armenia, ASEAN HQ, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Republic of Congo, Costa Rica, Croatia, Cyprus, Quantity: 18,411 systems Lot/code info: All GE Healthcare MR Systems. UDIs: 01008148480204781120092321QED3257; 01008148480204851119053021QED2493; 010088483808097321301223488; 010088483808097321301408170; (01)00846082115971(11)160923921)PG45; 01008148480200031117031321QED1184; 01008148480200031117052221QED1241; 01008148480200031117061221QED1268; 01008148480200031117082921QED1348; 01008148480200031118061521QED1775; 01008148480200031118072621QED1888; 01008148480200031118110721QED2090; 010081484802000311120010221QED2892; 010081484802000311120090121QED3227; 01008148480208071921QED1881; 01008148480202491118091321QED1990; 01008148480202491118110121QED2080; 01008148480202491119021421QED2282; 01008148480202491119022121QED2296; 01008148480202491119061321QED2525; 01008148480202491119062821QED2548; 01008148480202491119080121QED2598; 01008148480202491119082921QED; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111. US System ID numbers: 3422, 00506MRS01, 030022MR01, 1000000047, 1000000576, 1000001238, 1000001348, 1000002760, 1000004048, 1000004074, 1000004278, 1000004288, 1000004456, 1000004458, 1000004646, 1000004953, 1000004954, 1000004956, 1000004986, 1009000, 1118313, 1323566, 201261MR, 201418MR2, 201445750W, 201447MRW, 201456MRX, 201579MRW, 201632MR, 201634MRW, 201639MR3T, 201669MR2, 201730MR, 201773MR, 201836MRW, 201840MR, 201858MRW, 201871MR, 201894GEMR, 201967MR, 202223MR, 202269MR, 20
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.