Recall Z-1778-2024— GE Medical Systems, SCS

Name: FDA recall Z-1778-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-18

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, SCS, initiated 2024-03-18. It names one FDA 510(k) clearance: K181403. Product: GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems. Reason: 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..

Recalling firm: GE Medical Systems, SCS
Classification: Class II
Status: Ongoing
Initiated: 2024-03-18
Firm location: Buc, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K181403 — Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare·cleared 2018-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.