Recall Z-0780-2010 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems (Cleveland) Inc
MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications.
| Date | Feb 19, 2010 (initiated Dec 7, 2009) |
| Status | Terminated |
| Reason | Polymeric RF connector block on the tabletop overheated and eventually ignited during scanning due to combination of arcing of electrical components associated with the RF trap assembly located below the connector and flame rating of the connector block material. |
| Root cause | Other |
| Action | An "Urgent-Field Safety Notice" dated December 4, 2009 was issued via certified mail to customers. The notification letter described the affected product, problem, hazard involved and action to be taken by customer. The customer will ensure to maintain frequent contact with patients during scanning and that the patient comfort kit is installed for all patient studies. The Customer will be visited by a Philips Service Representative to inspect their MRI System and install the newly remanufactured RF Connector Block. Additionally, step-by-step trap/cable installation instructions including pi |
| Quantity | 290 units |
| Distribution | Worldwide distribution- United states: (AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, LA, MA, MD, ME, MN, MO, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA & WI), ARGENTINA, BRAZIL, CANADA, CHINA, CYPRUS, FRANCE, GERMANY, GREECE, ITALY, JAPAN, KOREA, NEW ZEALAND, PAKISTAN, POLAND, RU |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003853 | INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 Philips Medical Systems (Cleveland), Inc., Feb 13, 2001 |