| Class 2 Device Recall Innova 2121IQ / 3131IQ |  |
Date Initiated by Firm | April 16, 2009 |
Date Posted | November 09, 2009 |
Recall Status1 |
Terminated 3 on December 03, 2015 |
Recall Number | Z-0138-2010 |
Recall Event ID |
52056 |
510(K)Number | K060259 K061163 |
Product Classification |
Cardiovascular Imaging System - Product Code JAA
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Product | Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
GE Medical Systems, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact | 262-544-3894 |
Manufacturer 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 |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JAA
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