FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Polaris, Nuclear Magnetic Resonance Imaging System, Magnet Subsystem, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".
- Recall number
- Z-2432-2010
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Polaris, Nuclear Magnetic Resonance Imaging System, Magnet Subsystem, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".
- Status
- Terminated
- Initiated
- 2008-09-19
- Posted
- 2010-09-17
- Terminated
- 2010-09-17
- Reason
- 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.
- 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
- 64 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.
- Lot, serial or model codes
- 64 units are identified as Site Numbers: 207065, 212785, 220006, 505407, 223017, 205895, 204190, 205768, 220999, 238085, 205525, 238028, 204948, 223009, 223002, 220037, 209625, 218044, 238212, 209558, 205770, 238069, 205649, 217569, 205578, 204510, 212961, 220029, 203039, 209543, 205581, 209621, 204151, 238251, 205643, 209282, 220024, 209658, 205579, 203525, 223267, 238139, 204535, 203519, 223033, 205769, 238008, 204902, 223028, 238024, 209573, 209622, 205724, 220021, 220032, 218137, 220023, 204539, 238031, 209695, 209719, 209743, 238072, and 205825.
- 510(k) numbers
- ["K003853","K011296"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28