Recall Z-0021-2014 ยท OWB Interventional Fluoroscopic X-Ray System
GE Healthcare, LLC
GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
| Date | Oct 17, 2013 (initiated Aug 16, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems. |
| Root cause | Process control |
| Action | Consignees were sent on 8/12/2013 a GE Healthcare "Urgent Medical device Correction" letter dated August 12, 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology /Cardiology /Surgery Department and Radiologists /Cardiologists /Surgeons. The letter described the Safety Issue, safety Instructions, Affected Product details, Product Correction and Contact Information (US 800-437-1171, Japan 0120 055 919). |
| Quantity | 2184 (1063 US. 1121 OUS) |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and except ND, SD and VT, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022322 | INNOVA AND INNOVA 2000 S Ge Medical Systems, Inc., Oct 8, 2002 |
| K023178 | INNOVA 4100 Ge Medical Systems, Inc., Nov 26, 2002 |
| K945375 | ADVANTX LCA GE Medical Systems, Jan 30, 1995 |
| K960575 | ADVANTX LCV+ GE Medical Systems, May 7, 1996 |
| K974367 | ADVANTX LCN, ADVANTX LCLP GE Medical Systems, Feb 13, 1998 |
| K993037 | LCV+ VERSION 2 Ge Medical Systems, Inc., Feb 14, 2000 |