Events

Recall of EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Ultrasound, Inc..

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
    71105
  • Event Risk Class
    Class 2
  • Event Number
    Z-1631-2015
  • Event Initiated Date
    2015-04-14
  • Event Date Posted
    2015-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136135
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Reason
    When epiq 5 ultrasound system, without the pediatric cardiology option, is set up to "metric" and weight and/or height is entered, a unit conversion error may result in the incorrect display of their values and incorrect calculation of the patients body surface area (bsa).
  • Action
    Philips sent the Urgent-Medical Device Correction-Philips Model EPIQ5 Ultrasound system and the Urgent-Medical Device Correction-Philips Model EPIQ7 Ultrasound system letters, both dated 2015 APR 14, to their US consignees. Philips sent the Urgent-Field Safety Notice-Philips Model EPIQ5 Ultrasound system letter and the Urgent-Field Safety Notice-Philips Model EPIQ7 Ultrasound system letter (both letters dated 2015 APRIL 14) to their foreign consignees. The EPIQ5 or EPIQ7 Ultrasound systems WITHOUT the Pediatric Cardiology option are affected. Philips issued two Field Change Orders (FCO) to their Field Service Engineer to install upgraded software: -FCO 79500340 for EPIQ5 -FCO 79500341 for EPIQ7 Customers with questions can call Philips Customer Service at 1-800-722-9377. Field Service Engineers (FSE) to install software version 1.3.3 per FCO 79500340 instructions for EPIQ5 5 and per FCO 79500341 instructions for EPIQ7.

Device

EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option
  • Model / Serial
    ********************SYSTEM BASE ID IN THE US*****************************  US114C0207, US114C0208, US114C0209, US114C0287, US114C0308, US114C0323, US114C0330, US114C0445, US114C0713, US114C0714, US114C0731, US115C0139, US115C0464, US115C0465, US115C0470, US115C0471, US115C0537, US115C0538, US115C0539, US115C0576, US115C0607, US214C0042, US214C0084, US214C0103, US214C0104, US214C0105, US214C0141, US214C0142, US214C0162, US214C0180, US214C0434, US215C0068, US215C0069, US215C0070, US215C0072, US215C0073, US215C0074, US215C0171, US215C0172, US215C0178, US215C0179, US215C0180, US215C0306, US215C0307, US215C0308, US215C0406, US215C0407, US215C0449, US215C0450, US215C0512, US215C0513, US215C0514, US215C0516, US215C0534, US215C0535, US215C0538, US215C0539, US215C0571, US215C0572, US215C0573, US215C0615, US215C0616, US215C0617, US215C0618, US215C0619, US215C0620, US215C0624, US215C0625, US215C0626, US215C0627, US215C0713, US215C0714, US215C0715, US215C0716, US215C0717, US215C0769, 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USD14C0757, USD14C0762, USD14C0763, USD14C0764, USD14C0765, USD14C0877, USD14C0878, USD14C0879, USD14C0880, USD14C0881, USD14C0882, USD14C0883, USD14C0884, USD14C0885, USD14C0965, USD14C0966, USD14C0967, USD14C0968, USD14C0969, USD14C0970, USD14C0971, USD14C1019, USD14C1020, USD14C1021, USD14C1022, USD14C1023, USD14C1041, USD14C1042, USD14C1043, USN13C0341, USN13C0342, USN13C0394, USN13C0395, USN13C0396, USN13C0458, USN13C0463, USN13C0576, USN13C0577, USN13C0578, USN14C0032, USN14C0033, USN14C0034, USN14C0035, USN14C0036, USN14C0039, USN14C0103, USN14C0185, USN14C0186, USN14C0240, USN14C0366, USN14C0367, USN14C0380, USN14C0408, USN14C0418, USN14C0442, USN14C0464, USN14C0467, USN14C0468, USN14C0471, USN14C0472, USN14C0535, USN14C0536, USN14C0696, USN14C0697, USN14C0779, USN14C0886, USN14C0887, USN14C0943, USN14C0944, USN14C0945, USO13C0118, USO13C0119, USO13C0120, USO13C0346, USO13C0347, USO13C0348, USO13C0349, USO13C0351, USO13C0355, USO13C0356, USO13C0357, USO13C0380, USO13C0419, USO13C0458, USO13C0474, USO13C0475, USO13C0476, USO13C0477, USO13C0478, USO13C0479, USO13C0480, USO13C0481, USO13C0484, USO13C0485, USO13C0513, USO13C0514, USO13C0515, USO13C0516, USO13C0526, USO13C0527, USO13C0528, USO13C0529, USO13C0530, USO13C0531, USO13C0532, USO13C0533, USO13C0534, USO13C0535, USO13C0536, USO13C0537, USO13C0538, USO13C0539, USO13C0552, USO13C0575, USO13C0576, USO13C0577, USO13C0578, USO13C0579, USO13C0580, USO13C0581, USO13C0582, USO13C0583, USO13C0584, USO13C0585, USO13C0586, USO13C0587, USO13C0588, USO13C0613, USO14C0034, USO14C0054, USO14C0055, USO14C0081, USO14C0095, USO14C0097, USO14C0166, USO14C0278, USO14C0279, USO14C0280, USO14C0281, USO14C0282, USO14C0340, USO14C0377, USO14C0378, USO14C0380, USO14C0480, USO14C0481, USO14C0517, USO14C0570, USO14C0609, USO14C0610, USO14C0660, USO14C0662, USO14C0663, USO14C0664, USO14C0665, USO14C0666, USO14C0805, USO14C0806, USO14C0807, USO14C0808, USO14C0846, USO14C1090, USO14C1092, USO14C1117, and USO14C1118.    *********************SYSTEM BASE ID IN CANANA****************************  US115C0433, US115C0495, US115C0496, US115C0497, US115C0498, US115C0499, US115C0571, US215C0348, US215C0566, US215C0567, US215C0679, US215C1042, US315C0090, US315C0404, US315C0405, US315C0406, US414C0604, US714C0076, US714C0297, US814C0111, US914C0200, USD14C0156, USN14C0382, USN14C0383, USN14C0384, USO14C0511, USO14C0512, and USO14C0566.     ********************SYSTEM BASE ID IN OTHER COUNTRIES******************  US114B0005, US114B0006, US114C0081, US114C0082, US114C0107, US114C0110, US114C0143, US114C0144, US114C0145, US114C0146, US114C0147, US114C0148, US114C0192, US114C0193, US114C0194, US114C0211, US114C0238, US114C0309, US114C0320, US114C0348, US114C0363, US114C0366, US114C0408, US114C0409, US114C0442, US114C0446, US114C0532, US115C0017, US115C0052, US115C0053, US115C0054, US115C0100, US115C0101, US115C0137, US115C0138, US115C0141, US115C0178, US115C0179, US115C0180, US115C0181, US115C0212, US115C0213, 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USN14C0031, USN14C0037, USN14C0100, USN14C0143, USN14C0144, USN14C0187, USN14C0188, USN14C0238, USN14C0239, USN14C0310, USN14C0312, USN14C0363, USN14C0364, USN14C0368, USN14C0379, USN14C0381, USN14C0425, USN14C0426, USN14C0465, USN14C0466, USN14C0596, USN14C0597, USN14C0598, USN14C0599, USN14C0600, USN14C0616, USN14C0617, USN14C0623, USN14C0656, USN14C0657, USN14C0693, USN14C0694, USN14C0695, USN14C0730, USN14C0792, USN14C0793, USN14C0794, USN14C0884, USN14C0885, USN14C0888, USN14C0889, USN14C0890, USN14C0891, USN14C0939, USN14C0942, USN14C0946, USN14C1043, USN14C1045, USO13C0359, USO13C0360, USO13C0362, USO13C0363, USO13C0364, USO13C0365, USO13C0366, USO13C0367, USO13C0368, USO13C0369, USO13C0387, USO13C0395, USO13C0398, USO13C0404, USO13C0405, USO13C0406, USO13C0407, USO13C0455, USO13C0456, USO13C0464, USO13C0466, USO13C0467, USO13C0468, USO13C0469, USO13C0482, USO13C0483, USO13C0594, USO13C0596, USO13C0611, USO13C0612, USO13C0614, USO13C0615, USO13C0630, USO13C0679, USO13C0684, USO13C0686, USO14C0029, USO14C0030, USO14C0031, USO14C0032, USO14C0033, USO14C0035, USO14C0036, USO14C0037, USO14C0038, USO14C0039, USO14C0040, USO14C0093, USO14C0094, USO14C0123, USO14C0124, USO14C0277, USO14C0339, USO14C0376, USO14C0438, USO14C0439, USO14C0476, USO14C0477, USO14C0479, USO14C0514, USO14C0515, USO14C0516, USO14C0565, USO14C0567, USO14C0568, USO14C0569, USO14C0607, USO14C0608, USO14C0611, USO14C0612, USO14C0659, USO14C0667, USO14C0718, USO14C0719, USO14C0720, USO14C0763, USO14C0803, USO14C0804, USO14C0844, USO14C0923, USO14C0924, USO14C1115, USO14C1116, USO14C1181, and USO14C1182.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. || Part Number: 989605408541 With || 453561736761 (1.1) || 453561750041 (1.1.1) || 453561753651 (1.1.2) || 453561772231 (1.2) || 453561772611 (1.2.1) || 453561786571 (1.2.2) || 453561785081 (1.3) || 453561800581 (1.3.1) || 453561805181 (1.3.2) || Diagnostic ultrasound imaging and fluid flow analysis.
  • Manufacturer
    Philips Ultrasound, Inc.

Manufacturer

Philips Ultrasound, Inc.
  • Manufacturer Address
    Philips Ultrasound, Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA