Z-0137-2010

GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positioner, a vascular or...

Name: Z-0137-2010 GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positioner, a vascular or...
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 GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital... 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-0137-2010
Status: Terminated
Initiated: 2009-04-16
Posted: 2009-11-09
Terminated: 2015-12-03
Recalling firm: GE Healthcare
Product: GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
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: 35
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: 80158241 06014VAS01 06063VAS01 082406100018 0828160011 205759CL2 207662OR4100 215662INNOVA1 216844INNOVA 228809VASC 22925941V2 309672M4100 414649DVI 508383IN4100 509575YM4100 6012884100SUR 715369INN4100 718518CVL1 801268INNOVA 812825INNOVA1 843789SP1 865373SP 865541CCL5 904BSSP 910907WAVAS1 9408984100 A56364110 BG4037XR01 HC1819XR09 HC2001XR02 M2030711 NO1017VA03 NO1064VA04 RU2526VA01 XF0160

Product code IYO

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)