GE Medical Systems, SCS: GE Healthcare Innova IGS 5, computed tomography x-ray system

Hazard

GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

Details from the source

Reason for recall: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly. Distribution: Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam Quantity: 21 units Lot/code info: UDI/DI 00840682124621, Serial Numbers: M2-23-042, M2-23-046, M2-23-048, M2-23-051, M2-24-001, M3-23-097, M3-23-098, M3-23-106, M3-23-108, M3-23-109, M3-23-111, M3-23-112, M3-23-114, M3-23-116, M3-23-123, M4-23-046, M4-23-053, M4-23-054, M4-23-055, M4-23-056, M4-24-001

UPC codes

00840682124621

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.