Z-2043-2008

Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first...

Name: Z-2043-2008 Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first...
Creator: GE Healthcare
Published: 2008-01-14
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-01-14 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare began a recall of Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane system with a... on 2008-01-14. The reason FDA records is "Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2043-2008
Status: Terminated
Initiated: 2008-01-14
Posted: 2008-09-16
Terminated: 2011-12-17
Recalling firm: GE Healthcare
Product: Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane system with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were contacted by means of a Urgent Medical Device Correction letter dated 1/14/07. The letter is addressed to; Hospital Administrator, Hospital Risk Management Department, Manger of Radiology/Cardiology and Radiologists/Cardiologists. The letter describes the affected product and safety issue. The letter offers recommendations, solutions and provides contact information. If you have questions contact the firm: In the US contact the call center at 800-437-1171, option 4 and other countries should contact your local GE Healthcare field service representative.
Quantity in commerce: 4 units
Distribution: USA: AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, OH OR, PA, SC, TN, TX, WI, AK, AL, AR, AZ, CT, DE, GA, HI, IA, ID, KS, KY,LA ME, MI, MN, MS, MT, ND, NE, NH, NY, OK, RI, UT, VA, WA, WI, WV. OUSA: Hungary Algeria Argentina Australia Austria Belarus Belgium Bosnia Brazil Bulgaria Canada Chile China Columbia Czech Republic Denmark Egypt Finland France Georgia Germany Greece Guadeloupe Guatemala Honduras Hong Kong India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Korea Kuwait Kuwait Latvia Lebanon Malaysia Malta Mexico Morocco Netherlands New Zealand Nigeria Norway Pakistan Panama Poland Portugal Puerto Rico Romania Russian Federation Saudi Arabia Singapore Spain Sweden Switzerland Syria Taiwan Thailand Turkey United Kingdom Uruguay Venezuela Yugoslavia
Product codes and lots: ECXV1402B 4146492121 COR373252 N4192939

Product code MQB

K061163Class IIInnova 2121Iq, Innova 3131Iq, Innova 4100, Innova 4100Iq, Innova 3100, Innova 3100Iq, Innova 2100Iq with Innova Ivus OptGe Medical Systems, LLC / cleared 2006-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)