MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications.
This recall has been terminated (originally issued February 19, 2010).
- Recall Initiated
- December 7, 2009
- Posted
- February 19, 2010
- Terminated
- September 19, 2012
- Recall Number
- Z-0780-2010
- Quantity
- 290 units
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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, RUSSIA, SWITZERLAND, TAIWAN & UNITED KINGDOM.
Lot / Code Info
Model #781230. All lots
Root Cause
Other
Action Taken
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 pictures are being drafted to ensure correct installation of cabling. If you need any further information or support concerning this issue, please contact your local Philips representative or 1-800-722-9377.