Devices

Device Recall Innova 3100/ 3100IQ with InnovaIQ Table Option

Model / Serial
00000008C20323, 00000519107BU7, 00000007C20116, 00000464098BU3, - 00000000057WV0, 00000000086WV9, 00000000130WV5, 00000000050WV5, 00000000083WV6, 00000000193WV3, 00000000203WV0, and 00000000076WV0.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDEN, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, ITALY, ISRAEL, IRELAND, INDIA, HONG KONG, GERMANY, FRANCE, FINLAND, CZECH REPUBLIC, and AUSTRALIA.
Product Description
Innova 3100/ 3100IQ system with InnovaIQ Table Option || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, || rotational imaging procedures.
Manufacturer
Ge Healthcare, Llc
1 Event
- Recall of Device Recall Innova 3100/ 3100IQ with InnovaIQ Table Option

Manufacturer

Ge Healthcare, Llc

Manufacturer Address
Ge Healthcare, Llc, 3000 N Grandview Blvd, Waukesha WI 53188-1615
Manufacturer Parent Company (2017)
General Electric Company
Source
USFDA

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