Recall Z-0540-2010 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Medical Systems, LLC
GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems. 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 procedure
| Date | Dec 16, 2009 (initiated Oct 14, 2009) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential limit switch failure with Innova 2121IQ and 3131IQ (Biplane) systems that may impact patient safety. A potential limit switch failure could occur due to collision between the lateral plane of Innova Positioner and other equipment in the room. This collision may break the x-ray and positioning switches, and may not allow exam completion. To date, no in |
| Root cause | Employee error |
| Action | GE Healthcare issued an "Urgent Medical Device Correction" notice dated October 14, 2009. The letter was addressed to Hospital Administrators/Risk mangers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact GE Healthcare Systems at 1-800-437-1171, option 4 (U.S.) or contact your local GE Healthcare Service Representative. |
| Quantity | 114 |
| Distribution | Worldwide Distribution -- Including the UNITED STATES, YEMEN, UNITED KINGDOM, TAIWAN, SINGAPORE, RUSSIA, ROMANIA, MALAYSIA, LYB IA, JAPAN, ITALY, IRELAND, INDONESIA, INDIA, GERMANY, FRANCE, EGYPT, CHILE , CANADA and BAHRAIN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060259 | DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 Ge Medical Systems, LLC, Feb 22, 2006 |