Z-2434-2010

Panorama 0.6T MRI Nuclear Magnetic Resonance Imaging System, Philips Panorama 0.6T Open MRI system, Picker...

Name: Z-2434-2010 Panorama 0.6T MRI Nuclear Magnetic Resonance Imaging System, Philips Panorama 0.6T Open MRI system, Picker...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-09-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-09-19 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Panorama 0.6T MRI Nuclear Magnetic Resonance Imaging System, Philips Panorama 0.6T Open MRI system, Picker International, Inc. World Headquarters 595 Miner... on 2008-09-19. The reason FDA records is "Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2434-2010
Status: Terminated
Initiated: 2008-09-19
Posted: 2010-09-17
Terminated: 2010-09-17
Recalling firm: Philips North America LLC
Product: Panorama 0.6T MRI Nuclear Magnetic Resonance Imaging System, Philips Panorama 0.6T Open MRI system, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite.
FDA root cause: Other
Action: Philips issued an Urgent Correction letter dated 09/19/2008 to their consignees, identifying the reason for the recall and the affected products. The firm issued the Field Change Order (FCO) 78100232. Field service engineers will visit each consignee and conduct an inspection of the magnets venting system of Edge, Vista, Eclipse, Polaris, Infinion, and Panorama 0.6T MRI systems. The consignees should contact the Philips Call Center at 1-800-772-9377, #5 #2 and reference "FCO 78100232".
Quantity in commerce: 38 units
Distribution: Nationwide Distribution: USA., including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. There is no distribution to foreign consignees.
Product codes and lots: 38 units are identified as Site Numbers: 521187, 531720, 104899, 105667, 504932, 531768, 521133, 521921, 104916, 103807, 519694, 530401, 104929, 105512, 521760, 520678, 104845, 105663, 546676, 548145, 104018, 505970, 505942, 104793, 533077, 539135, 505762, 532478, 533238, 532743, 534855, 530465, 534254, 544106, 103990, 520193, 104050, and 505406.

Product code LNH

K013858Class IIInfinion 0.6T Mr Imaging SystemPhilips Medical Systems (Cleveland), Inc. / cleared 2002-01-22

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)