The Recall Desk

FDA (Devices) recall action 67685

Philips Medical Systems North America Inc. recalled 2 products on 2014-03-26

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-03-26
Critical
0
Units
—

Why these products were 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 by

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2014-03-26

    Philips EPIQ 5 Ultrasound System Recalled for Incorrect Doppler Velocity Readings

    Philips is recalling EPIQ 5 Ultrasound Systems because they may report incorrect Doppler velocities when using specific settings, potentially affecting diagnostic accuracy.

    Product
    Philips Model EPIQ 5 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 D
    Category
    Distribution
    40 states
  • HighFDA (Devices)··2014-03-26

    Philips EPIQ 7 Ultrasound System Recalled for Incorrect Doppler Velocity Readings

    Philips is recalling EPIQ 7 Ultrasound Systems because they may report incorrect Doppler velocities when using specific settings, potentially affecting diagnostic accuracy.

    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 D
    Category
    Distribution
    40 states