CLASS II Device recall · Reported 27 Nov 2013 · FDA Enforcement Report

EPIQ 7 Ultrasound System recalled by Philips Medical Systems North

Philips Medical Systems North America is recalling EPIQ 7 Ultrasound System, distributed nationwide in the US. The recall was initiated on 17 Oct 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesTRACE 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.

Quantity recalled306 units total (206 international; 100 in the US).

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0368-2014
FDA event ID: 66662
Recalling firm: Philips Medical Systems North America, Bothell, WA
Classification: Class II
Status: Terminated
Recall initiated: 17 Oct 2013
FDA classified: 20 Nov 2013
Reported: 27 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

17 Oct 2013	Recall initiated by company
20 Nov 2013	Classified by FDA	+34 days
27 Nov 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Connecticut Hawaii Illinois Indiana Kentucky Massachusetts Maine Michigan North Carolina Oregon Pennsylvania Texas Washington

Questions about this recall

Is EPIQ 7 Ultrasound System recalled?

Yes. Philips Medical Systems North America recalled EPIQ 7 Ultrasound System on 17 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-0368-2014.

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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