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FDA Device recall Z-1632-2015

EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number…

On 2015-05-27 the FDA classified a Class II recall of EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number… by Philips Ultrasound, citing when EPIQ 7 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 incorr….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1632-2015
ClassificationClass II
Statusterminated
Initiated2015-04-14
Published2015-05-27
Last updated2026-09-13 11:53 UTC
CompanyPhilips Ultrasound
Distributionn/a

Product

EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (1.2) 453561772631 (1.2.1) 453561786591 (1.2.2) 453561785101 (1.3) 453561800601 (1.3.1) 453561805211 (1.3.2) Diagnostic ultrasound imaging and fluid flow analysis

Reason

When EPIQ 7 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).

Identifiers

code_info
********************SYSTEM BASE ID IN THE US***************************** US114B0056, US114B0057, US114B0160, US114B…********************SYSTEM BASE ID IN THE US***************************** US114B0056, US114B0057, US114B0160, US114B0187, US114B0188, US114B0189, US114B0224, US114B0282, US114B0283, US114B0303, US114B0318, US114B0355, US114B0393, US114B0394, US114B0400, US114B0401, US114B0403, US114B0435, US114B0468, US114B0495, US114B0527, US114B0528, US114B0529, US114B0537, US114B0538, US114B0540, US114B0541, US114B0542, US114B0544, US114B0545, US114B0547, US114B0548, US114B0552, US114B0569, US114B0570, US114B0583, US114B0612, US114B0702, US114B0705, US114B0706, US114B0707, US114B0709, US114B0710, US114B0711, US114B0712, US115B0010, US115B0011, US115B0013, US115B0014, US115B0043, US115B0044, US115B0045, US115B0046, US115B0047, US115B0048, US115B0049, US115B0090, US115B0125, US115B0166, US115B0167, US115B0264, US115B0267, US115B0269, US115B0270, US115B0377, US115B0378, US115B0480, US115B0481, US115B0482, US115B0483, US115B0519, US115B0520, US115B0586, US115B0592, US115B0593, US115B0594, US115B0595,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1632-2015%22

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