Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1264-2014 — 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 resu

U.S. FDA — Device Enforcement · United States · 2014-02-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1264-2014
Date of alert: 2014-02-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Medical Systems North America Inc.
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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