Z-1631-2015Class II

EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G...

Name: Z-1631-2015 EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G...
Creator: Philips Ultrasound, Inc.
Published: 2015-04-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-04-14 / Terminated / root cause: software

FDA source

Philips Ultrasound, Inc. began a recall of 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... on 2015-04-14. FDA classified it as Class II and gives the reason as "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...". 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-1631-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-14
Posted: 2015-05-19
Terminated: 2016-08-08
Recalling firm: Philips North America LLC
Product: 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.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: 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).
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: Total 1108 units (490 units in US and 618 units outside the US)
Distribution: Worldwide Distribution
Product codes and lots: ********************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, US215C0770, US215C0771, US215C0772, US215C0773, US215C0845, US215C1047, US215C1048, US314C0105, US314C0237, US314C0323, US314C0324, US314C0325, US314C0445, US314C0447, US315C0100, US315C0101, US315C0217, US315C0407, US315C0408, US315C0409, US315C0410, US315C0412, US315C0413, US315C0414, US315C0416, US315C0417, US413C0106, US413C0166, US413C0167, US413C0188, US413C0189, US413C0190, US413C0193, US413C0306, US413C0307, US413C0308, US413C0309, US413C0456, US413C0458, US414C0209, US414C0232, US414C0233, US414C0479, US414C0533, US414C0535, US513C0066, US513C0103, US513C0104, US513C0383, US513C0384, US513C0389, US513C0390, US513C0586, US513C0588, US514C0082, US514C0083, US514C0104, US514C0105, US514C0106, US514C0117, US514C0240, US514C0301, US514C0561, US514C0563, US514C0564, US514C0565, US514C0566, US514C0593, US514C0594, US514C0595, US514C0596, US514C0597, US514C0672, US514C0735, US514C0736, US514C0737, US613C0035, US613C0050, US613C0058, US613C0059, US613C0060, US613C0061, 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USD14C0756, 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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US514C0685, US514C0729, US514C0730, US514C0731, US514C0733, US514C0734, US514C0738, US514C0739, US514C0740, US614C0023, US614C0025, US614C0071, US614C0153, US614C0158, US614C0190, US614C0191, US614C0193, US614C0231, US614C0242, US614C0279, US614C0331, US614C0334, US614C0420, US614C0439, US614C0440, US614C0479, US614C0480, US614C0668, US614C0689, US614C0690, US614C0780, US614C0781, US614C0844, US614C0845, US714C0072, US714C0073, US714C0122, US714C0124, US714C0128, US714C0165, US714C0166, US714C0171, US714C0217, US714C0218, US714C0251, US714C0270, US714C0289, US714C0290, US714C0323, US714C0324, US714C0368, US714C0369, US714C0462, US714C0507, US714C0509, US714C0510, US714C0511, US714C0530, US714C0531, US714C0532, US714C0568, US714C0580, US714C0582, US714C0664, US714C0670, US714C0697, US714C0698, US714C0699, US714C0737, US814C0011, US814C0012, US814C0013, US814C0026, US814C0027, US814C0028, US814C0074, US814C0112, US814C0113, US814C0114, US814C0115, US814C0116, US814C0156, US814C0173, US814C0174, US814C0227, US814C0229, US814C0243, US814C0264, US814C0265, US814C0266, US814C0267, US814C0309, US814C0310, US814C0453, US814C0454, US814C0455, US814C0456, US814C0457, US814C0459, US814C0460, US814C0463, US814C0464, US814C0465, US814C0466, US814C0467, US814C0470, US814C0471, US814C0505, US814C0506, US814C0507, US814C0509, US814C0511, US814C0533, US814C0534, US814C0536, US814C0564, US814C0565, US814C0566, US814C0567, US814C0568, US814C0569, US814C0570, US814C0571, US814C0572, US814C0601, US814C0602, US914C0015, US914C0016, US914C0024, US914C0036, US914C0050, US914C0051, US914C0052, US914C0199, US914C0201, US914C0205, US914C0244, US914C0269, US914C0307, US914C0308, US914C0309, US914C0310, US914C0311, US914C0312, US914C0322, US914C0323, US914C0324, US914C0359, US914C0374, US914C0375, US914C0484, US914C0616, US914C0632, US914C0633, US914C0634, US914C0635, US914C0738, US914C0743, US914C0871, US914C0872, US914C0908, US914C0909, US914C0910, US914C0915, US914C0956, US914C0959, US914C0960, USD13C0032, USD13C0037, USD13C0069, USD13C0074, USD13C0232, USD13C0238, USD13C0259, USD13C0260, USD13C0261, USD13C0262, USD13C0289, USD13C0290, USD13C0364, USD13C0444, USD13C0727, USD13C0728, USD13C0730, USD13C0731, USD13C0732, USD13C0733, USD13C0734, USD13C0786, USD13C0787, USD14C0040, USD14C0041, USD14C0042, USD14C0043, USD14C0044, USD14C0045, USD14C0046, USD14C0112, USD14C0113, USD14C0155, USD14C0157, USD14C0158, USD14C0159, USD14C0160, USD14C0161, USD14C0162, USD14C0163, USD14C0164, USD14C0280, USD14C0282, USD14C0283, USD14C0286, USD14C0287, USD14C0364, USD14C0365, USD14C0366, USD14C0367, USD14C0399, USD14C0401, USD14C0409, USD14C0475, USD14C0489, USD14C0517, USD14C0518, USD14C0519, USD14C0520, USD14C0521, USD14C0659, USD14C0665, USD14C0666, USD14C0667, USD14C0668, USN13C0245, USN13C0309, USN13C0310, USN13C0311, USN13C0312, USN13C0313, USN13C0378, USN13C0459, USN13C0462, USN13C0470, USN13C0498, USN13C0500, USN13C0503, USN13C0505, USN13C0531, USN13C0594, USN13C0659, 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1631-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1631-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-19
Z-1632-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-19

Product code IYN

K132304Class IIEpiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. / cleared 2013-08-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)