GE Medical Systems, SCS
9 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for GE Medical Systems, SCS and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-10-15FDA-DeviceClass IIAW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
- 2024-05-15FDA-DeviceClass IIGE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
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.
- 2024-05-15FDA-DeviceClass IIGE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
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.
- 2024-05-15FDA-DeviceClass IIGE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
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.
- 2024-05-15FDA-DeviceClass IIGE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
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.
- 2024-05-15FDA-DeviceClass IIGE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
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.
- 2024-05-15FDA-DeviceClass IIGE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
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.
- 2024-05-15FDA-DeviceClass IIGE Healthcare Innova IGS 5, computed tomography x-ray system
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.
- 2024-02-14FDA-DeviceClass IISenographe Pristina
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
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