Z-0780-2010

MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended for use with...

Name: Z-0780-2010 MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended for use with...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2009-12-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-12-07 / Terminated

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications on 2009-12-07. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0780-2010
Status: Terminated
Initiated: 2009-12-07
Posted: 2010-02-19
Terminated: 2012-09-19
Recalling firm: Philips North America LLC
Product: MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
FDA 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 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.
Quantity in commerce: 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, RUSSIA, SWITZERLAND, TAIWAN & UNITED KINGDOM.
Product codes and lots: Model #781230. All lots

Product code LNH

K003853Class IIInfinion 1.5T Mr Imaging System, Model MRI 100Philips Medical Systems (Cleveland), Inc. / cleared 2001-02-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)