Z-1264-2014Class II

Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis...

Name: Z-1264-2014 Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis...
Creator: Philips Medical Systems North America Inc.
Published: 2014-02-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-02-28 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Inc. began a recall of Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204... on 2014-02-28. FDA classified it as Class II and gives the reason as "A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates...". 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-1264-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-28
Posted: 2014-03-20
Terminated: 2016-12-12
Recalling firm: Philips North America LLC
Product: Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated b
Root cause tag: software
FDA root cause: Software design
Action: The firm, Philips Healthcare Ultrasound, sent an "Medical Device Correction" letters dated 2014 Feb 28 via Certified Mail via the USPS by March 5, 2014. The letters described the product, problem and actions to be taken. The customers were instructed to not use HPRF in PW Doppler mode, to avoid the noted issues. Philips Field Service Engineer will be contacting them to schedule software upgrade to the systems free of charge. If you need any further information or support concerning this issue, please contact the Quality Specialist II at 978-659-4519 or your local Philips representative.
Quantity in commerce: 1267 total :670 units in US and 1267 units Internationally (which includes 11 units in Canada)
Distribution: Worldwide Distribution: US (nationwide) including states of: AL, AK, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV; and countries of: Australia, Austria, Belgium, Canada, Chili, Ecuador, Egypt, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea Rep, Malaysia, Netherlands, New Zealand, Norway, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.
Product codes and lots: All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1264-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1263-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1264-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20

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)