Events

Recall of Device Recall Philips IntelliVue Information Center

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
    50215
  • Event Risk Class
    Class 2
  • Event Number
    Z-0034-2011
  • Event Initiated Date
    2008-11-21
  • Event Date Posted
    2010-10-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74994
  • 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
    Arrhythmia Detector and Alarm - Product Code DSI
  • Reason
    Potential for internal sound amplifier to malfunction which could delay treatment.
  • Action
    On 11/20/08, Philips began sending the URGENT-Medical Device Correction letter to their consignees via e-mails. On 11/21/08, the firm sent out the recall letter via United State Postal Service. The letter states the affected device as Philips IntelliVue Information Centers, running on the HP rp5700 PC platform equipped with an active speaker solutions using a DB-15 to 3.5 mm cable set. The consignees are advised to ensure that the audible alarm system is clear, free of noise and distortion and adjustable to different sound levels which is explained in p. 5-47 "Adjusting Alarm Tone Volume" of IntelliVue of the Instruction for Use, Release K Manual, supplied with the hardware, Philips Part Number 453564062301. Consignees can call Philips Healthcare Customer Care Service Center at 1-800-722-9377, #3, #1 and reference FCO 99862012.

Device

Device Recall Philips IntelliVue Information Center
  • Model / Serial
    Serial numbers are:  4810A03287, 4810A03260, 4810A03261, 4810A03262, 4810A04902, 4810A04906, 4810A04907, 4810A04908, 4810A04909, 4810A04910, 4810A04911, 4810A04912, 4810A05422, 4810A05423, 4810A11902, 4810A03367, 4810A03368, 4810A03369, 4810A03370, 4810A03372, 4810A03231, 4810A03240, 4810A03241, 4810A03242, 4810A03254, 4810A03255, 4810A03256, 4810A03257, 4810A03243, 4810A03244, 4810A03245, 4810A02772, 4810A04096, 4810A04097, 4810A04094, 4810A04095, 4810A04084, 4810A04085, 4810A03710, 4810A03711, 4810A03407, 4810A03408, 4810A03409, 4810A03410, 4810A04494, 4810A03934, 4810A03935, 4810A04768, 4810A04783, 4810A04809, 4810A04810, 4810A03631, 4810A04805, 4810A04598, 4810A11904, 4810A04053, 4810A11873, 4810A05158, 4810A05167, 4810A03078, 4810A03762, 4810A11903, 4810A05378, 4810A04798, 4810A04799, 4810A04800, 4810A04764, 4810A04765, 4810A04801, 4810A04802, 4810A04803, 4810A04804, 4810A04784, 4810A04785, 4810A04786, 4820A10136, 4820A10138, 4820A10139, 4820A10124, 4820A10125, 4820A11906, 4820A11905, 4810A03623, 4810A04796, 4810A04763, 4810A04777, 4810A04778, 4810A04779, 4810A04780, 4810A04781, 4810A09398, 4810A11851, 4810A03643, 4810A04664, 4810A04650, 4810A04651, 4810A04652, 4810A09748, 4810A09749, 4810A04565, 4810A04567, 4810A04568, 4810A05277, 4810A05278, 4810A05280, 4810A05281, 4810A04437, 4810A04438, 4810A05288, 4810A05289, 4810A05290, 4810A05291, 4810A05292, 4810A05293, 4810A05282, 4810A05283, 4810A05284, 4810A05285, 4810A05286, 4810A05287, 4810A04573, 4810A04574, 4810A04663, 4810A02713, 4810A02714, 4810A02715, 4810A02716, 4810A02762, 4810A02770, 4810A05397, 4810A05398, 4810A05399, 4810A05400, 4810A11881, 4810A05424, 4810A09648, 4810A09649, 4810A09650, 4810A09651, 4810A03699, 4810A03700, 4810A03702, 4810A03703, 4810A02941, 4810A02942, 4810A02943, 4810A02944, 4810A02945, 4810A02946, 4810A02947, 4810A02948, 4810A09687, 4810A11858, 4810A11877, 4810A02976, 4810A02962, 4810A02963, 4810A02964, 4810A02965, 4810A02966, 4810A02922, 4810A05425, 4810A05413, 4810A05417, 4810A04557, 4810A04555, 4810A04556, 4810A04504, 4810A04505, 4810A04506, 4810A04507, 4810A04508, 4810A04509, 4810A04510, 4810A04511, 4825A06062, 4825A06065, 4825A06063, 4825A06064, 4810A09047, 4810A09048, 4810A09049, 4810A09050, 4810A09051, 4810A09052, 4810A09053, 4810A09054, 4810A09055, 4810A09056, 4810A09084, 4810A09085, 4810A09086, 4810A09087, 4810A09302, 4815A05570, 4815A05571, 4815A05574, 4815A05573, 4810A05247, 4810A09756, 4810A11893, 4810A11894, 4810A10015, 4810A10016, 4810A10018, 4810A10019, 4810A10020, 4810A10021, 4810A02915, 4810A02874, 4825A06101, 4825A06102, 4825A06116, 4825A06117, 4810A09436, 4810A10078, 4810A10079, 4810A10083, 4810A09634, 4810A09635, 4810A09654, 4810A09655, 4810A09656, 4810A09657, 4810A09640, 4810A09645, 4810A09658, 4810A09641, 4810A09642, 4810A09659, 4810A09660, 4810A09661, 4810A09662, 4810A09463, 4810A09425, 4810A09462, 4810A09464, 4810A09892, 4810A09894, 4810A09876, 4810A09877, 4810A09878, 4810A09879, 4810A09880, 4810A09881, 4810A09895, 4810A09893, 4810A09882, 4810A09883, 4810A09884, 4810A05147, 4810A04228, 4810A04292, 4810A04293, 4810A04294, 4815A05914, 4815A05915, 4815A05882, 4815A05883, 4815A05884, 4815A05901, 4815A05902, 4815A05903, 4815A05904, 4815A05905, 4815A05906, 4810A02786, 4810A02787, 4810A02788, 4825A06053, 4825A06049, 4825A06050, 4825A06051, 4825A06052, 4825A06044, 4825A06045, 4825A06046, 4825A06047, 4825A06048, 4825A06092, 4825A06038, 4825A06039, 4825A06040, 4825A06041, 4825A06042, 4825A06043, 4825A06056, 4810A04970, 4810A04971, 4810A04974, 4810A04975, 4810A04976, 4810A04977, 4810A04978, 4810A04979, 4810A05030, 4810A05031, 4810A03323, 4810A03324, 4810A03325, 4810A09359, 4810A09360, 4810A05083, 4810A04544, 4810A04545, 4810A04546, 4810A04547, 4810A04548, 4810A04550, 4810A04551, 4810A04552, 4810A04553, 4810A09215, 4810A09199, 4810A09200, 4810A09201, 4810A09202, 4810A09203, 4810A09212, 4810A04558, 4810A04559, 4810A04560, 4810A04561, 4810A04562, 4810A04563, 4810A04564, 4810A04048, 4810A04049, 4810A04050, 4810A04051, 4810A11857, 4810A10087, 4810A10088, 4810A10089, 4810A10090, 4810A10091, 4810A10092, 4810A10093, 4810A10094, 4815A05948, 4815A05949, 4815A05950, 4815A05951, 4815A05895, 4815A05896, 4815A05897, 4815A05898, 4810A04812, 4810A04813, 4810A03652, 4810A03653, 4810A03839, 4810A11896, 4810A11897, 4810A03575, 4810A03576, 4810A03577, 4810A03578, 4810A03581, 4810A03582, 4810A03583, 4810A03584, 4810A05406, 4810A05407, 4810A09574, 4810A09575, 4810A09576, 4810A09577, 4810A09578, 4810A09579, 4810A04662, 4810A04673, 4810A04674, 4810A03206, 4810A04303, 4810A04304, 4810A04305, 4810A04306, 4810A04386, 4810A05459, 4810A05460, 4810A05461, 4810A05504, 4815A05813, 4815A05814, 4815A05818, 4810A04124, 4810A04125, 4810A04126, 4810A04127, 4810A04128, 4810A04129, 4810A04352, 4810A04353, 4810A04354, 4810A04355, 4815A05604, 4815A05617, 4815A05618, 4815A05619, 4815A05634, 4810A04980, 4810A04998, 4810A04999, 4810A05000, 4810A05001, 4810A05002, 4810A03229, 4810A03205, 4810A03249, 4810A03204, 4810A03230, 4810A03250, 4810A05024, 4810A04981, 4810A04982, 4810A04983, 4810A04984, 4810A05025, 4810A05026, 4810A05027, 4810A05028, 4810A05009, and 4810A05012.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". || The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. || Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
  • 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