—#91106

Product

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.

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K023178, K031637, K033244, K042053, K050489
Affected lot / code info: 00000008C20323, 00000519107BU7, 00000007C20116, 00000464098BU3, - 00000000057WV0, 00000000086WV9, 00000000130WV5, 00000000050WV5, 00000000083WV6, 00000000193WV3, 00000000203WV0, and 00000000076WV0.

Why it was recalled

GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety.

Root cause (FDA determination)

Device Design

Action the firm took

Consignees were sent on 6/3/10 a GE Healthcare "Urgent Medical device Correction" letter dated May 12, 2010. The letter was addressed to Hospital Administrators/ Risk Mangers, Managers of Radiology/Cardiology and Radiologists/ Cardiologists. The letter included the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. Customers are to contact a service representative immediately if they notice any cable damage.

Recalling firm

Firm: Ge Healthcare, Llc
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-06-03
Posted by FDA: 2010-06-29
Terminated: 2015-09-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91106. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.