Z-0368-2014Class II

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

Name: Z-0368-2014 EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid...
Creator: Philips Medical Systems North America Inc.
Published: 2013-10-17
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-10-17 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Inc. began a recall of EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis on 2013-10-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0368-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-17
Posted: 2013-11-20
Terminated: 2014-07-16
Recalling firm: Philips North America LLC
Product: EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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).
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0368-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0368-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-20

Product code IYN

K132304Class IIEpiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. / cleared 2013-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)