Z-0138-2010

Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System

Name: Z-0138-2010 Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System
Creator: GE Medical Systems, LLC
Published: 2009-04-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-04-16 / Terminated / root cause: design

FDA source

GE Medical Systems, LLC began a recall of Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System on 2009-04-16. The reason FDA records is "Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0138-2010
Status: Terminated
Initiated: 2009-04-16
Posted: 2009-11-09
Terminated: 2015-12-03
Recalling firm: GE Healthcare
Product: Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contra
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were sent on May 1, 2009 a GE Healthcare " Urgent Medical Device Correction" letter dated April 16, 2009. The letter was addressed to Hospital Administrator/ Risk Manger, Mangers of Radiology/ Cardiology, and Radiologists/ Cardiologists. The letter described the problem, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
Quantity in commerce: 15 AND 46 UNLOCATED
Distribution: Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, POLAND, RUSSIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, ROMANIA, ISRAEL, UKRAINE, YEMEN, BELARUS, and AUSTRALIA.
Product codes and lots: SYSTEM ID: 0847160005 542120XR02 561548BIP 561881BP1 630856H3131 817465AR3131 985867INNOVA31 COR373301 EG1000VA01 LY1086VA01 M4166990 05448VAS01 VAD2121 YE1002VA01 YV0365 NOT LOCOLIZED S/N CHILLER 798080-21 796259-09 794637-08 795371-01 796133-12 796259-05 796464-08 796464-13 796464-15 796767-05 796941-03 796941-04 796941-07 796941-09 797178-05 797179-03 797179-08 797179-12 797449-03 797449-06 797632-02 797812-04 797812-09 797812-10 797812-12 767326-03 770355-02 772153-13 767746-05 785678-16 794637-11 799172-07 799347-03 799347-05 796260-01 783679-01 797178-03 797179-07 797179-09 797179-11 797812-14 797812-16 799347-02 798449-01 798449-02 798449-03

Product code JAA

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)