Recall Z-2376-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Healthcare, LLC
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: 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
| Date | Sep 13, 2012 (initiated Aug 16, 2012) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover. |
| Root cause | Software design |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated August 16, 2012, to all affected consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, and Contact Information. Consignees were instructed that hospital staff should wait for Photo or Image to appear on the display (when store photo function is performed) before start of the next short duration fluoroscopy acquisition. For questions customers were instructed to call: United States (800) 437-1171 Japan: 0120 - 055 - 919 For other countries consignees should con |
| Quantity | 240 (133 US and 107 OUS) |
| Distribution | Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, HI, IK, IL IN, IA, KS, LA, MD, MA, MI, MN,MO, NV, NH, NH, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI,.and internationally to: AUSTRALIA, AZERBAIJIN, BAHRAIN, BELARUS, BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, EGYPT, |
| 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 |
| K061163 | INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT Ge Medical Systems, LLC, Jun 7, 2006 |
| K091658 | GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 GE Healthcare, Jun 29, 2009 |