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Terminated

Innova 2121-IQ/3131--1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

FDA Recall Z-0407-2011 · Posted 2010-11-17

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMQB
Date Initiated2009-08-05
Date Terminated2014-01-16
Product Quantity32 (2121IQ); 37 (3131IQ)

Reason for Recall

GE Healthcare has become aware of a potential issue regarding Innova systems with GE Fluoro UPS 20KVA that may impact patient safety. GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to maintain fluoroscopy availability for approximately 5 minutes should there be a main power failure. Once power is restored, the equipment power will be returned to the main hospital power. UPS fluoro ba

Firm Action

GE Healthcare sent an "Urgent Medical Device Correction" letter on August 5, 2009 to all Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology and Radiologists / Cardiologists. The letter was dated August 4, 2009, and described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For questions regarding this recall call (262) 548-2731.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK ,OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI and the countries of ANGOLA, BELARUS, BULGARIA, CANADA, EGYPT, FRANCE, GERMANY, HUNGARY, IRELAND, MEXICO, ITALY, NIGERIA, NORWAY, POLAND, PORTUGAL, RUSSIAN FEDERATION, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, TUNISIA, TURKEY, and the UNITED KINGDOM

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061163INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPTGe Medical Systems, LLC · 2006-06-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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