Recall Z-1163-2014 ยท OWB Interventional Fluoroscopic X-Ray System
GE Healthcare, LLC
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures.
| Date | Mar 10, 2014 (initiated Dec 11, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. No injuries have been reported due to this issue. |
| Root cause | Software design |
| Action | GE Healthcare sent an "Urgent Medical Device Correction " letter dated December 10, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter described the Safety Issue, The long term solution is to provide a software correction for all of the affected systems that were distributed. The plan for public warning is to contact all customers with an affected system by means of an Urgent Medical Device Correction letter within the US. In the US this will be sent by a traceable means (either US Postal Service with |
| Quantity | 257(159 US, 98 OUS) |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MS, MO, NV, NJ, NY, NC, ND, OH, OK OR, PA, PR, RI, SC, TN, TX, UT, VA,WA,WY and WI., and the countries of ARGENTINA, AUSTRALIA, CANADA, CHINA, CZECH REPUBLIC, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023178 | INNOVA 4100 Ge Medical Systems, Inc., Nov 26, 2002 |
| K031637 | INNOVA 3100 GE Medical Systems, Aug 22, 2003 |
| K033244 | DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION Ge Medical Systems, Inc., Oct 16, 2003 |
| K042053 | INNOVA 4100, INNOVA 3100 Ge Medical Systems, Inc., Aug 26, 2004 |
| K050489 | INNOVA 2100 Ge Medical Systems, LLC, Mar 11, 2005 |