Recall Z-1922-2010 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Ge Healthcare, Llc
Innova 3100/ 3100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures.
| Date | Jun 29, 2010 (initiated Jun 3, 2010) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety. |
| Root cause | Device Design |
| Action | Consignees were sent on 6/3/10 a GE Healthcare "Urgent Medical device Correction" letter dated May 12, 2010. The letter was addressed to Hospital Administrators/ Risk Mangers, Managers of Radiology/Cardiology and Radiologists/ Cardiologists. The letter included the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. Customers are to contact a service representative immediately if they notice any cable damage. |
| Quantity | 13 |
| Distribution | Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDEN, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, ITALY, ISRAEL, IRELAND, INDIA, HONG KONG, GERMANY, FRANCE |
| 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 |