Agency classClass IIOur severity:High FDA (Devices)·Z-1263-2014·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect diagnostic data (overstated velocities) which could lead to misdiagnosis, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Medical Systems North America Inc. is recalling the Philips Model EPIQ 5 Ultrasound System. The recall affects 489 units, with 227 located in the United States and 262 internationally. The systems are intended for diagnostic ultrasound imaging and fluid flow analysis, specifically to assist in diagnosing the existence, location, and severity of cardiac or vascular stenosis.

The recall is due to a software defect where the system may report incorrect Doppler velocities. Specifically, if the user employs High Pulse Repetition Frequency (HPRF) with multiple sample volume gates while in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the results table may be overstated. This issue affects all systems running software versions prior to v1.1.2, including v1 and v1.1, which were shipped prior to February 28, 2014.

Healthcare facilities and users of these systems should contact Philips Medical Systems North America Inc. for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.

The recalled product

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…
Manufacturer: Philips Medical Systems North America Inc.
Category: Medical Device — Diagnostic Imaging
Hazard: mis-diagnosis
software-defect

Distribution

Distributed nationwide across the United States.

The notice also names 40 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Philips Medical Systems North America Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Philips Medical Systems North America Inc.

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Same hazard · mis diagnosis