Events

Recall of Device Recall ACHIEVA 1.5T and INTERA 1.5T Nuclear Magnetic Resonance Imaging

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems North America Co. Phillips.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52040
  • Event Risk Class
    Class 2
  • Event Number
    Z-0469-2011
  • Event Initiated Date
    2009-05-01
  • Event Date Posted
    2010-11-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81965
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    Combined use of the synergy flex-m / shoulder coil 1.5t increases the chance of rf interaction and heating up of the coil. this may result in possible burns of the patient.
  • Action
    Philips issued URGENT-Field Safety Notice letters dated May 1, 2009 and October 14, 2009 to their consignees. The letter informed customers that the firm will replace the "old" Flex M/Shoulder Coils with a new Flex-M coil. Consignees could contact Philips Healthcare Call Center at 800-722-9377, #5, #3, #1 and reference FCO 78100290 for any questions.

Device

Device Recall ACHIEVA 1.5T and INTERA 1.5T Nuclear Magnetic Resonance Imaging
  • Model / Serial
    Site Numbers:  10009, 10353, 10409, 10432, 13056, 13057, 13894, 17648, 25958, 25986, 26201, 26219, 26269, 35394, 37986, 38111, 38134, 38143, 38303, 38304, 38420, 38438, 38966, 41345, 41391, 45016, 50336, 59435, 59637, 59712, 62450, 62658, 62832, 63046, 76320, 76321, 76359, 76475, 76847, 82546, 82619, 83080, 83301, 83303, 83306, 83325, 83394, 83396, 83804, 83876, 83940, 83946, 83995, 84433, 84477, 84478, 84700, 84820, 84860, 84887, 84899, 85119, 85139, 85141, 85157, 85158, 85172, 85433, 85442, 85500, 85684, 85685, 85686, 85688, 86019, 86056, 86080, 86085, 86121, 86147, 86184, 86236, 86280, 86281, 86292, 86293, 86313, 86317, 86334, 86335, 86381, 86404, 86406, 86407, 86410, 86557, 86560, 86570, 86595, 86596, 86968, 87011, 87018, 87033, 87038, 87053, 87135, 87145, 87146, 87147, 87148, 87161, 87168, 87183, 87188, 87309, 87310, 87526, 87527, 87605, 87607, 100214, 100459, 100460, 100462, 100469, 100478, 100745, 100785, 100786, 100826, 100832, 100916, 101084, 101111, 101138, 101162, 101165, 101206, 101313, 101347, 101408, 101420, 101429, 101431, 101477, 101481, 101551, 101561, 101584, 101585, 101595, 101608, 101780, 101874, 101877, 101878, 101934, 101946, 101976, 102003, 102004, 102018, 102095, 102110, 102137, 102492, 102547, 102548, 102561, 102569, 102571, 102671, 102709, 102718, 102724, 102889, 102907, 102933, 102975, 102978, 102980, 103041, 103062, 103068, 103099, 103126, 103135, 103136, 103142, 103143, 103149, 103166, 103171, 103207, 103215, 103243, 103247, 103291, 103324, 103333, 103347, 103351, 103417, 103450, 103509, 103530, 103540, 103544, 103547, 103552, 103579, 103580, 103582, 103592, 103611, 103631, 103665, 103688, 103703, 103770, 103782, 103789, 103811, 103847, 103904, 103946, 104022, 104032, 104054, 104069, 104070, 104082, 104095, 104102, 104138, 104163, 104193, 104336, 104340, 104343, 104378, 104392, 104393, 104446, 104467, 104532, 104639, 104765, 104800, 104808, 104871, 104886, 104887, 104897, 104900, 104901, 104912, 104918, 104919, 104942, 105148, 105252, 105271, 105290, 105303, 105314, 105315, 105317, 105348, 105368, 105471, 105486, 105488, 105624, 105657, 105687, 105695, 105741, 105925, 105926, 105929, 105938, 225313, 250050, 250122, 250156, 250293, 250890, 500009, 500034, 504243, 504249, 504342, 504353, 504400, 504403, 504409, 504412, 504527, 504531, 504543, 504608, 504628, 504662, 504670, 504738, 504866, 505021, 505049, 505050, 505275, 505337, 505357, 505490, 505514, 505568, 505678, 505777, 505785, 505914, 505940, 505941, 505943, 506034, 506044, 506188, 506190, 506203, 506219, 506296, 506324, 506389, 506570, 506691, 506777, 519124, 519127, 519129, 519147, 519216, 519522, 519525, 519545, 520002, 520113, 520354, 520709, 521429, 530363, 530651, 531767, 533741, 536318, 536649, 542669, 544006, 544503, 545940, 546669, 547235, 550391, 556698, 557719, 557722, 557723, 557724, 557791, 557793, 557801, 557805, 557806, 557807, 557813, 557814, 557843, 557844, 557904, 558118, 558147, 558177, 558200, 558369, 558371, 558374, 558381, 558382, 41923351, and 43668550.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VA, WA, WI, WV, WY, and Washington DC. There were no foreign consignees.
  • Product Description
    The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva and Intera 1.5T MR systems". || The Identification of the Synergy Flex-M/ Shoulder Coil 1.5T can be found on the driver box. The 12nc of the affected system is labeled as 4522-131-6656x.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA