Class 2 Device Recall Philips IntelliVue Information Center

• Date Initiated by Firm: November 21, 2008
• Date Posted: October 08, 2010
• Recall Status: Terminated on October 12, 2010
• Recall Number: Z-0034-2011
• Recall Event ID: 50215
• 510(K)Number: K023698
• Product Classification: Arrhythmia Detector and Alarm - Product Code DSI
• Product: 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Philips Medical Systems North America Co. Phillips; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Philips Customer Care Service Center; 800-722-9377
• Manufacturer Reason for Recall: Potential for Internal Sound Amplifier to malfunction which could delay treatment.
• FDA Determined Cause: Component change control
• 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.
• Quantity in Commerce: 424 units in US.
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DSI and Original Applicant = PHILIPS MEDICAL SYSTEMS