FDA Medical Device Recalls (openFDA)
GE Healthcare: 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.
- Recall number
- Z-2043-2008
- 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.
- Status
- Terminated
- Initiated
- 2008-01-14
- Posted
- 2008-09-16
- Terminated
- 2011-12-17
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- ECXV1402B 4146492121 COR373252 N4192939
- 510(k) numbers
- ["K061163"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28