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Z-1264-2014 Class II Terminated

Recalled by Philips Medical Systems North America Inc. — Bothell, WA

FDA device recall Z-1264-2014 was initiated by Philips Medical Systems North America Inc. on February 28, 2014 and is designated Class II. 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 samp… The recall status is terminated (terminated December 12, 2016). Affected quantity: 1267 total :670 units in US and 1267 units Internationally (which includes 11 units in Canada).

Recall Details

Product Type: Devices
Report Date: March 26, 2014
Initiation Date: February 28, 2014
Termination Date: December 12, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1267 total :670 units in US and 1267 units Internationally (which includes 11 units in Canada)

Product Description

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.

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

Distribution Pattern

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.

Code Information

All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014).

Other recalls by Philips Medical Systems North America Inc.

Z-1263-2014 Class II — Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imag (February 28, 2014)
Z-1225-2014 Class II — Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and (February 6, 2014)
Z-1232-2014 Class II — Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs (February 6, 2014)
Z-0368-2014 Class II — EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnost (October 17, 2013)