Z-0479-2011

Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F...

Name: Z-0479-2011 Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2009-01-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-01-21 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh... on 2009-01-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0479-2011
Status: Terminated
Initiated: 2009-01-21
Posted: 2010-11-26
Terminated: 2010-12-30
Recalling firm: Philips North America LLC
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.
Product code: KPR System, X-Ray, Stationary
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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.

Product code KPR

K031535Class IIPhilips Easydiagnost ElevaPhilips Medical Systems North America Co. / cleared 2003-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)