Recall Z-2387-2018— GE Medical Systems, SCS
Class II · Terminated
Class II FDA medical device recall by GE Medical Systems, SCS, initiated 2018-03-29, terminated 2021-06-15. It names 2 FDA 510(k) clearances: K122457, K111209. Product: Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems. Reason: The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use..
- Recalling firm
- GE Medical Systems, SCS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-29
- Terminated
- 2021-06-15
- Firm location
- Buc, France
510(k) clearances named in this recall
2 on FDA's record- K122457 — GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
- K111209 — INTEGRATED INNOVA - S5I SYSTEM OPTION
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
Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
Reason for recall
The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.