Recalls / —

—#64549

Product

GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system. GE Healthcare Americas P.O.Box 414, Milwaukee, Wisconsin 53201, U.S.A.

FDA product code

MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K050489

Affected lot / code info

00000459256BU4, 00000459553BU4, 00000459554BU2, 00000459555BU9, 00000459556BU7, 00000459557BU5, 00000460056BU5, 00000460057BU3, 00000460058BU1, 00000460059BU9, 00000460060BU7, 00000460063BU1, 00000460065BU6, 00000460066BU4, 00000460067BU2, 00000461642BU1, 00000461643BU9, 00000461644BU7, 00000461645BU4, 00000462898BU8, 00000462899BU6, 00000462900BU2, 00000462901BU0, 00000462902BU8, 00000462903BU6, 00000462904BU4, 00000462905BU1, 00000462906BU9, 00000462907BU7, 00000463613BU2, 00000463630BU4, 00000463631BU2, 00000463632BU0, 00000463633BU8, 00000463634BU6, 00000463636BU1, 00000463637BU9, 00000463638BU7, 00000463639BU5, 00000463841BU7, 00000467440BU4, 00000467441BU2, 00000467442BU0, 00000467443BU8, 00000467444BU6, 00000467445BU3, 00000467446BU1, 00000467447BU9, 00000467448BU7, 00000467449BU5, 00000467451BU1, 00000469541BU7, 00000469542BU5, 00000469543BU3, 00000469544BU1, 00000469545BU6, 00000469546BU6, 00000469547BU4, 00000469548BU2, 00000469549BU0, 00000469550BU8, 00000470643BU8, 00000470644BU6, 00000470645BU3, 00000470646BU1, 00000470647BU9, 00000470648BU7, 00000470649BU5, 00000470650BU3, 00000470651BU1, 00000470652BU9, 00000471493BU7, 00000471494BU5, 00000471495BU2, 00000471496BU0, 00000471497BU8, 00000471498BU6, 00000471499BU4, 00000471500BU9, 00000471501BU7, 00000471502BU5, 00000472676BU6, 00000477489BU9, 00000477490BU7, 00000477491BU5, 00000477492BU3, 00000477493BU1, 00000477494BU9, 00000477495BU6, 00000477496BU4, 00000477497BU2, 00000477498BU0, 00000477893BU2, 00000479230BU5, 00000479231BU3, 00000479232BU1, 00000479233BU9, 00000479234BU7, 00000479235BU4, 00000479236BU2, 00000479237BU0, 00000479238BU8, 00000479239BU6, 00000479937BU5, 00000479945BU8, 00000479946BU6, 00000479947BU4, 00000479948BU2, 00000479949BU0, 00000479950BU8, 00000479951BU6, 00000479952BU4, 00000479953BU2, 00000479954BU0, 00000482511BU3, 00000482512BU1, 00000482513BU9, 00000482514BU7, 00000482515BU4, 00000482516BU2, 00000482517BU0, 00000482518BU8, 00000482519BU6, 00000482520BU4, 00000484054BU2, 00000485072BU3, 00000485074BU9, 00000485075BU6, 00000485076BU4, 00000485077BU2, 00000485078BU0, 00000485079BU8, 00000485080BU6, 00000485081BU4, 00000487465BU7, 00000487466BU5, 00000487469BU9, 00000487470BU7, 00000487471BU5, 00000487472BU3, 00000487473BU1, 00000487474BU9, 00000491019BU6, 00000491020BU4, 00000491021BU2, 00000491022BU0, 00000491023BU8, 00000491025BU3, 00000491027BU9, 00000491028BU7, 00000491032BU9, 00000492823BU0, 00000492824BU8, 00000492825BU5, 00000492827BU1, 00000492828BU9, 00000492830BU5, 00000492831BU3, 00000494960BU8, 00000504480BU5, 00000508755BU6, 00004600057BU3

Why it was recalled

The systems do not contain a certification label on the C2 Cabinet (Beam-limiting control).

Root cause (FDA determination)

Other

Action the firm took

Starting on June 6, 2007, a GE service engineer will go to each affected site to affix certification labels on the affected devices.

Recalling firm

Firm

GE Healthcare

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern

World wide Distribution includes: AL, AR, AZ, CA,, CO, CT FL, GA, HI, ID, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI,and WV, and countries of ; Algeria, Australia, China, Denmark, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Kuwait, Latvia, New Zealand, Norway, Poland, Saudi Arabia, Singapore, Switzerland, Syrian Arab Republic, Turkey, and United Kingdom.

Timeline

Recall initiated

2006-06-06

Posted by FDA

2007-09-28

Terminated

2015-12-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #64549. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.