CLASS II Device recall · Reported 26 Mar 2014 · FDA Enforcement Report
Philips Model Epiq 7 Ultrasound System. Intended for diagnostic recalled
Philips Medical Systems North America is recalling Philips Model Epiq 7 Ultrasound System. Intended for diagnostic, distributed nationwide in the US. The recall was initiated on 28 Feb 2014 and the FDA has classified it as Class II.
Check your package
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-1264-2014
- FDA event ID
- 67685
- Recalling firm
- Philips Medical Systems North America, Bothell, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Feb 2014
- FDA classified
- 20 Mar 2014
- Reported
- 26 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 28 Feb 2014 | Recall initiated by company | |
| 20 Mar 2014 | Classified by FDA | +20 days |
| 26 Mar 2014 | Published in enforcement report | +6 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 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
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Why was it recalled?
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
Which lots are affected?
All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014).
Where was it sold?
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.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 67685| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Philips Model Epiq 5 Ultrasound System. Intended for diagnostic recalled | Philips Medical Systems North America | Other | Nationwide |
More recalls from Philips Medical Systems North America
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips HeartStart Home and OnSite recalled | Philips Medical Systems North America | Other | Nationwide |
| Device | CLASS II | Philips Model Epiq 5 Ultrasound System. Intended for diagnostic recalled | Philips Medical Systems North America | Other | Nationwide |
| Device | CLASS II | Philips HeartStart FR3 Automated External Defibrillator (AED) recalled | Philips Medical Systems North America | Device Malfunction | 20 states |
| Device | CLASS II | EPIQ 7 Ultrasound System recalled by Philips Medical Systems North | Philips Medical Systems North America | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |