Recall Z-0947-2013 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Healthcare, LLC
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.
| Date | Mar 13, 2013 (initiated Jan 21, 2013) |
| Status | Terminated |
| Reason | A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems. |
| Root cause | Nonconforming Material/Component |
| Action | GE Healthcare sent "URGENT MEDICAL DEVICE CORRECTION" letters dated January 18, 2013 and February 11, 2013 to all affected customers. The letters were addressed to Hospital Administrators / Risk Managers, Mangers of Radiology / Cardiology and Radiologists / Cardiologists. The letters described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The second letter dated February 11, 2013 was sent out to consignees which incorporated an additional model number (2270677-2) which was initially missed. Contact the firm 800-437-1171 for ques |
| Quantity | 297 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MN, MS,MO, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT , VA, WA, WV, WI and the countries of VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, SPAIN, SAUDI ARABIA |
| 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 |
| K052157 | INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ Ge Medical Systems, LLC, Aug 25, 2005 |