—#73602

Product

Edge Nuclear Magnetic Resonance Imaging System. "1.5T Edge High-Field Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K931544, K964626
Affected lot / code info: 28 units are identified as Site Numbers: 200300, 200320, 200692, 200717, 200896, 200922, 200997, 201507, 202500, 202610, 203528, 204199, 207459, 218110, 41127, 500322, 500326, 500327, 505573, 73004, 73440, 75163, 75724, 76855, 78528, 78544, 78842 and 79543.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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".

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-09-19
Posted by FDA: 2010-09-17
Terminated: 2010-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73602. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.