Philips Ultrasound, Inc.: 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.

Recall number

Z-1631-2015

Recalling firm

Philips Ultrasound, Inc.

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.

Status

Terminated

Initiated

2015-04-14

Posted

2015-05-19

Terminated

2016-08-08

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).

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

Total 1108 units (490 units in US and 618 units outside the US)

Distribution

Worldwide Distribution

Lot, serial or model codes

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   *********************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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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.

510(k) numbers

["K132304"]

PMA numbers

not on file

Product code

IYN

Firm FEI

3019216

Firm city

Bothell

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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