• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Philips Easy Diagnost Eleva Conventional R/F system

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Philips Easy Diagnost Eleva Conventional R/F system
see related information
Date Posted November 26, 2010
Recall Status1 Terminated on December 30, 2010
Recall Number Z-0479-2011
Recall Event ID 52100
Premarket Notification
510(K) Number
K031535 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany.
Code Information Site Numbers: 506250, 506251, 506276, 519152, 520209, 521153, 530573, 530607, 532426, 532779, 533491, 533574, 534207, 534419, 534644, 534647, 534675, 534803, 534945, 535378, 535437, 535785, 536051, 536458, 536522, 536636, 536637, 536687, 536765, 536840, 536933, 536941, 536973, 536985, 536994, 537013, 537087, 537091, 537179, 537186, 537492, 537518, 537571, 537689, 537761, 537796, 537803, 537863, 537945, 537946, 537970, 537971, 538237, 538328, 538351, 538407, 538451, 538458, 538462, 538477, 538480, 538519, 538759, 538812, 538814, 538866, 538891, 538901, 539040, 539095, 539101, 539103, 539237, 539291, 539310, 539339, 539377, 539378, 539379, 539411, 539419, 539488, 539501, 539519, 539527, 539529, 539530, 539557, 539590, 539683, 539785, 540022, 540163, 540187, 540361, 540380, 540445, 540457, 540459, 540624, 540788, 540810, 541011, 541054, 541063, 541078, 541083, 541093, 541348, 541402, 541494, 541535, 541614, 541694, 541721, 541803, 541838, 541850, 541872, 541884, 542061, 542121, 542122, 542205, 542308, 542401, 542521, 542537, 542589, 542593, 542716, 542829, 542849, 543136, 543144, 543224, 543241, 543249, 543275, 543297, 543331, 543369, 543415, 543426, 543619, 543620, 543660, 543723, 543754, 543755, 543771, 543776, 543803, 543841, 544075, 544113, 544172, 544228, 544236, 544297, 544341, 544417, 544480, 544481, 544568, 544648, 544654, 544695, 544937, 544999, 545000, 545038, 545120, 545163, 545166, 545213, 545231, 545234, 545244, 545391, 545452, 545710, 545746, 545780, 545783, 545824, 545844, 545923, 545948, 545951, 546029, 546155, 546490, 546524, 546551, 546583, 546602, 547054, 547189, 547243, 547297, 547304, 547371, 547598, 547599, 547655, 547657, 547744, 547758, 547759, 547798, 547936, 547937, 548021, 548276, 548290, 548302, 548382, 548559, 548784, 549008, 549080, 549269, 549270, 549381, 549416, 549509, 549557, 549616, 549663, 550072, 550079, 550197, 550313, 550591, 550804, 550936, 550960, 551005, 551416, 551573, 551616, 551645, 551721, 551759, 551941, 551954, 551980, 552204, 552205, 552211, 552324, 552363, 552364, 552407, 552502, 552579, 552594, 552626, 552640, 552917, 552918, 552965, 552966, 553013, 553172, 553207, 553224, 553230, 553275, 553349, 553387, 553441, 553448, 553455, 553563, 553850, 553893, 553900, 553926, 554061, 554483, 554581, 554641, 554721, 554722, 554769, 555052, 555269, 555458, 555524, 555574, 555626, 555964, 555993, 556124, 556621, 556622, 556726, 556785, 556984, 557177, 557259, 557272, 558437, 558596, 558734, 558775, 41443799, 41444441, 41658234, 41862667, 42039161, and 537967 / 49371595.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
For Additional Information Contact Philips Healthcare Call Center
800-722-9377
Manufacturer Reason
for Recall
Patient and image data can be exchanged when a patient is selected in the patient list and the examination tab is pressed with background query running at the same time. There is a risk that the data may then be linked to the incorrect patient, which may adversely affect diagnosis and treatment.
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Medical Systems issued URGENT-Device Correction letters dated January 27, 2009 to consignees describing the issue with the Easy Diagnost Eleva GXR RF systems. The consignees were informed of the potential for incorrect diagnosis or treatment if an incorrect image is used for diagnosis. Consignees should contact the Philips Healthcare Call Center at 800-722-9377, #5, #2 and reference "FC0 70600030" with any communication.
Quantity in Commerce 314 units
Distribution Nationside Distribution: USA, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PA, RI, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, and WV. Devices are not distributed to any foreign consignees.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
-
-