Philips Medical Systems North America Inc.: EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.

Recall number

Z-0368-2014

Recalling firm

Philips Medical Systems North America Inc.

Product

EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.

Status

Terminated

Initiated

2013-10-17

Posted

2013-11-20

Terminated

2014-07-16

Reason

A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD).

Root cause

Software design

Action

Affected customers will be notified via the Urgent-Field Safety Notice (FSN79500286), Philips Model EPIQ 7 Ultrasound system, dated 2013 October. Customers are informed that using the International System Date Format in the Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. may result in calculation errors in Gestational Age and Established Due Date (EDD). Philips will upgrade customer systems to software version 1.1, which corrects the issue, for a free of charge.

Quantity

306 units total (206 international; 100 in the US).

Distribution

Worldwide Distribution-USA (nationwide) including the states of CT, HI, IL, IN, KY, MA, ME, MI, NC, OR, PA, TX, and WA, and the countries of Australia, Austria, Belgium, Chile, Denmark, Finland, France, Germany, India, Ireland, Republic of Korea, Latvia, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, and United Kingdom.

Lot, serial or model codes

TRACE ITEM SERIAL NUMBERS in the UNITED STATES: US713B0171, US713B0207, US813B0017, US813B0018, US813B0019, US813B0020, US813B0022, US813B0023, US813B0024, US813B0025, US813B0122, US813B0123, US813B0125, US813B0127, US813B0128, US813B0129, US813B0131, US813B0132, US813B0134, US813B0135, US813B0233, US813B0234, US813B0235, US813B0236, US813B0237, US813B0238, US813B0239, US813B0240, US813B0423, US813B0424, US813B0425, US813B0426, US813B0427, US813B0428, US813B0429, US813B0430, US813B0431, US813B0432, US813B0433, US813B0434, US913B0033, US913B0034, US913B0035, US913B0036, US913B0037, US913B0038, US913B0039, US913B0040, US913B0057, US913B0060, US913B0061, US913B0062, US913B0063, US913B0064, US913B0065, US913B0066, US913B0106, US913B0107, US913B0108, US913B0109, US913B0110, US913B0111, US913B0112, US913B0113, US913B0144, US913B0176, US913B0201, US913B0256, US913B0257, US913B0350, US913B0363, US913B0364, US913B0365, US913B0366, US913B0367, US913B0368, US913B0369, US913B0380, US913B0384, US913B0395, US913B0396, US913B0397, US913B0398, US913B0399, US913B0400, US913B0401, US913B0402, US913B0409, US913B0441, US913B0444, US913B0445, US913B0446, US913B0447, US913B0503, US913B0522, US913B0614, US913B0615, US913B0616, US913B0618, US913B0619, and USO13B0043.  TRACE ITEM SERIAL NUMBERS INTERNATIONAL:  US513B0224, US513B0295, US513B0387, US513B0560, US613B0299, US713B0085, US713B0086, US713B0118, US713B0119, US713B0120, US713B0122, US713B0123, US713B0126, US713B0149, US713B0171, US713B0172, US713B0192, US713B0193, US713B0194, US713B0195, US713B0204, US713B0205, US713B0206, US713B0208, US713B0324, US713B0325, US713B0358, US713B0359, US713B0437, US713B0439, US713B0440, US713B0532, US713B0537, US713B0573, US713B0574, US713B0575, US713B0576, US713B0577, US713B0578, US713B0579, US713B0580, US713B0581, US713B0582, US713B0583, US713B0584, US713B0586, US713B0587, US713B0588, US713B0589, US713B0590, US713B0592, US713B0593, US713B0594, US713B0595, US813B0015, US813B0016, US813B0032, US813B0037, US813B0038, US813B0039, US813B0121, US813B0151, US813B0152, US813B0153, US813B0154, US813B0155, US813B0156, US813B0157, US813B0158, US813B0159, US813B0160, US813B0161, US813B0162, US813B0163, US813B0164, US813B0183, US813B0184, US813B0185, US813B0186, US813B0187, US813B0188, US813B0189, US813B0190, US813B0191, US813B0192, US813B0193, US813B0194, US813B0195, US813B0196, US813B0232, US813B0396, US813B0397, US813B0398, US813B0399, US813B0400, US813B0401, US813B0402, US813B0403, US813B0404, US813B0405, US813B0406, US813B0407, US813B0408, US813B0409, US813B0410, US813B0411, US813B0468, US813B0469, US813B0470, US813B0471, US813B0472, US813B0473, US813B0474, US813B0475, US813B0476, US813B0477, US813B0478, US813B0479, US813B0480, US913B0026, US913B0027, US913B0028, US913B0029, US913B0030, US913B0031, US913B0032, US913B0041, US913B0051, US913B0059, US913B0085, US913B0086, US913B0101, US913B0102, US913B0103, US913B0104, US913B0105, US913B0130, US913B0132, US913B0133, US913B0134, US913B0135, US913B0137, US913B0138, US913B0139, US913B0140, US913B0141, US913B0142, US913B0143, US913B0177, US913B0178, US913B0179, US913B0185, US913B0202, US913B0216, US913B0217, US913B0218, US913B0219, US913B0220, US913B0221, US913B0222, US913B0223, US913B0232, US913B0252, US913B0253, US913B0254, US913B0255, US913B0259, US913B0260, US913B0299, US913B0300, US913B0301, US913B0302, US913B0303, US913B0316, US913B0317, US913B0318, US913B0319, US913B0332, US913B0333, US913B0336, US913B0337, US913B0338, US913B0339, US913B0340, US913B0349, US913B0359, US913B0360, US913B0385, US913B0408, US913B0458, US913B0459, US913B0486, US913B0487, US913B0488, US913B0489, US913B0490, US913B0499, US913B0504, US913B0505, US913B0506, US913B0565, US913B0566, US913B0567, US913B0568, USO13B0040, and USO13B0041.

510(k) numbers

["K132304"]

PMA numbers

not on file

Product code

IYN

Firm FEI

1000524572

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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