—#82008

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)

FDA product code: IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K023178, K033244, K042053, K052157, K052412, K061163
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-04-16
Posted by FDA: 2009-11-09
Terminated: 2015-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82008. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.