Recall Z-0911-2014 ยท OWB Interventional Fluoroscopic X-Ray System
GE Healthcare, LLC
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult an
| Date | Feb 3, 2014 (initiated Dec 12, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will |
| Root cause | Device Design |
| Action | The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated December 11, 2013 to its consignees. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/ Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The consignees were instructed to immediately contact your local GE Healthcare Service Representative if you observe any inappropriate performance or excessive movement of the monitor suspension yoke. GE Healthca |
| Quantity | 816 (722 US, 94 OUS). |
| Distribution | Worldwide distribution: US (nationwide) including Guam and DC but excluding CT, DE, HI and RI; and internationally to: AUSTRALIA, BULGARIA, CANADA, CHILE, DOMINICAN REPUBLIC, GERMANY, HONDURAS, IRELAND, ITALY, KUWAIT, LEBANON, MALTA, NAMIBIA, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SPAIN, |
| FDA record | Open on fda.gov |