—#82007

Product

GE Healthcare, GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K050489, K052157, K052412, K061163
Affected lot / code info: SYSTEM ID: 850060731 853060205 82416020006 82416090003 82416120015 82416120016 82416210014 83016022101218 83016842101519 0002780363 00052VAS04 00052VAS05 00060VAS03 010120RX44 082416030012 082416130029 083016002001498 083016802101749 083016822101709 083016862101268 0910064010 110019RX13 1299563 17005VAS01 304526INNOVA 318449INNOVA3 407321INCL2 410368INNOVA1 503561CL1 503561CL4 526354XR13 573815BCR3 603882CATH1 609757IN2100 706774HT4 717217INN21 717544GECATH2 732776CATH4 732923INN 816347SLE2100 816861KCVAI2 816861KCVAI2 818INNOVAHMS1 828315FEP 910343NHIN3 A5152993 A5330714 B5483438 BG4033VA01 C5123626 GOLD010016 HR4106VA01 HR4107VA01 HU1173VA03 LV4000VA04 M4183841 M4484974 RO1180VA01 RU3301VA01 YV0562

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 #82007. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.