Philips Ultrasound, Inc.: EPIQ 5 Ultrasound System with 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)

Recall number

Z-1578-2015

Recalling firm

Philips Ultrasound, Inc.

Product

EPIQ 5 Ultrasound System with 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)

Status

Terminated

Initiated

2015-04-10

Posted

2015-05-05

Terminated

2016-02-29

Reason

When Epiq 5 Ultrasound System, WITH 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 calculation of the patients Body Surface Area (BSA).

Root cause

Software design

Action

Philips sent the Urgent-Medical Device Correction-Philips Model EPIQ5 and Ultrasound system letter, dated 2015 APRIL 10, and the Urgent-Medical Device Correction-Philips Model EPIQ7 and Ultrasound system letter, dated 2015 APRIL 10, letters to their consignees. These systems WITH Pediatric Cardiology option are affected. Philips issued two Field Change Orders (FCO) to their Field Service Engineer to install upgraded software: -FCO 79500336 for EPIQ5 -FCO 79500337 for EPIQ7 Customers with questions can call Philips Customer Service at 1-800-722-9377.

Quantity

751 units total (246 units in the US and 505 units outside the US)

Distribution

Worldwide Distribution - US (nationwide and DC) and Internationally to Norway, India, New Zealand, Bahrain, Sweden, Italy, Australia, France, Netherlands, Switzerland, Germany, Austria, and Turkey.

Lot, serial or model codes

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USO14C0158, USO14C0159, USO14C0160, and USO14C0188.   *****************************SYSTEM CODES IN CANADA********************  US115C0274, US115C0466, US115C0467, US115C0494, US214C0486, US215C0034, US215C0036, US215C0347, US414C0111, US414C0112, US414C0113, US414C0114, US414C0477, US414C0478, US514C0339, US614C0688, US614C0854, US914C0179, US914C0180, USN14C0237, and USO14C1093.   ****************************SYSTEM CODES IN OTHER COUNTRIES*************  US114C0077, US114C0078, US114C0079, US114C0080, US114C0105, US114C0106, US114C0109, US114C0190, US114C0191, US114C0284, US114C0285, US114C0361, US114C0362, US114C0365, US114C0378, US114C0405, US114C0406, US114C0407, US114C0443, US114C0505, US114C0531, US114C0533, US114C0672, US114C0673, US114C0675, US114C0730, US114C0751, US115C0018, US115C0055, US115C0097, US115C0098, US115C0099, US115C0215, US115C0275, US115C0383, US115C0449, US115C0450, US115C0463, US115C0564, US115C0566, US115C0573, US115C0574, US115C0616, US115C0647, US115C0648, 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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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