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
This recall has been terminated (originally issued September 17, 2010).
- Recall Initiated
- September 19, 2008
- Posted
- September 17, 2010
- Terminated
- September 17, 2010
- Recall Number
- Z-2434-2010
- Quantity
- 38 units
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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".