Z-0407-2011

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

Name: Z-0407-2011 Innova 2121-IQ/3131--1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and...
Creator: GE Healthcare, LLC
Published: 2009-08-05
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-08-05 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of Innova 2121-IQ/3131--1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full... on 2009-08-05. The reason FDA records is "GE Healthcare has become aware of a potential issue regarding Innova systems with GE Fluoro UPS 20KVA that may impact patient safety. GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to maintain fluoroscopy...". 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-0407-2011
Status: Terminated
Initiated: 2009-08-05
Posted: 2010-11-17
Terminated: 2014-01-16
Recalling firm: GE Healthcare
Product: Innova 2121-IQ/3131--1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: GE Healthcare has become aware of a potential issue regarding Innova systems with GE Fluoro UPS 20KVA that may impact patient safety. GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to maintain fluoroscopy availability for approximately 5 minutes should there be a main power failure. Once power is restored, the equipment power will be returned to the main hospital power. UPS fluoro ba
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: GE Healthcare sent an "Urgent Medical Device Correction" letter on August 5, 2009 to all Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology and Radiologists / Cardiologists. The letter was dated August 4, 2009, and described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For questions regarding this recall call (262) 548-2731.
Quantity in commerce: 32 (2121IQ); 37 (3131IQ)
Distribution: Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK ,OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI and the countries of ANGOLA, BELARUS, BULGARIA, CANADA, EGYPT, FRANCE, GERMANY, HUNGARY, IRELAND, MEXICO, ITALY, NIGERIA, NORWAY, POLAND, PORTUGAL, RUSSIAN FEDERATION, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, TUNISIA, TURKEY, and the UNITED KINGDOM
Product codes and lots: 2121IQ 2036882121 4146492121 05448VAS01 206598UWBP 214590EP2121 215576INNOVA2 253627INNOVA5 301295CATH 304526INNOVABP 3108252121A 3108252121B 316268BIPLANE 319272EP 4105502121 410614CV1 410614CV2 541743CL5 610526LAB3 610954BP1 612273INNOVA3 617636IN2121 713794LAB11 857307IN12121 857307IN22121 857307IN32121 904202WCL1 936WH2121 FHORLEP4 FHORLEP5 IE1100VA03 MCDEP VAD2121 3131IQ 4144473131 00026VAS01 00243VAS02 00440VAS04 10307VAS01 2197383131 281637SL3131 301295EP 309655FSP2B 309655FSP4A 317338PV4 410740CV 509474BIP 5135843131 540776LGVAS2 541382BP 542120XR02 561495DLBIP 561548BIP 561881BP1 615222BIH 617525IN13131 6263973131 630933INVLAB4 650493BIPL 713794LAB8 718579INNOVABP 773RES3131BP 814877BP 816932SL3131 817465AR3131 8184093131 985867INNOVA31 COR373252 COR373295 EG1000VA01 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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)