Recall Z-2042-2008 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Healthcare
Innova 2000's principle system components include a C-arm, image acquisition, processing and archiving capabilities.
| Date | Sep 16, 2008 (initiated Jan 14, 2008) |
| Status | Terminated |
| Reason | Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system |
| Root cause | Process control |
| Action | Consignees were contacted by means of a Urgent Medical Device Correction letter dated 1/14/07. The letter is addressed to; Hospital Administrator, Hospital Risk Management Department, Manger of Radiology/Cardiology and Radiologists/Cardiologists. The letter describes the affected product and safety issue. The letter offers recommendations, solutions and provides contact information. If you have questions contact the firm: In the US contact the call center at 800-437-1171, option 4 and other countries should contact your local GE Healthcare field service representative. |
| Quantity | 388 |
| Distribution | USA: AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, OH OR, PA, SC, TN, TX, WI, AK, AL, AR, AZ, CT, DE, GA, HI, IA, ID, KS, KY,LA ME, MI, MN, MS, MT, ND, NE, NH, NY, OK, RI, UT, VA, WA, WI, WV. OUSA: Hungary Algeria Argentina Australia Austria Belarus Be |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024200 | INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) Ge Medical Systems, Inc., Jan 16, 2003 |