Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0368-2014·Announced 2013-11-27

Philips EPIQ 7 Ultrasound System Recalled for Date Format Calculation Errors

Philips is recalling EPIQ 7 Ultrasound Systems because using the International System Date Format may cause calculation errors in Gestational Age and Established Due Date.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Philips Medical Systems North America Inc. is recalling the EPIQ 7 Ultrasound System, Models 795200, 795201, and 795202, software versions 1.0 and 1.0.1. The recall involves 306 units total, with 100 units distributed in the United States and 206 units distributed internationally.

The recall is due to a software defect where using the International System Date Format may result in calculation errors for Gestational Age (GA) and Established Due Date (EDD). This issue affects the accuracy of diagnostic ultrasound imaging and fluid flow analysis data.

The affected units were distributed nationwide in the United States, including in Connecticut, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Maine, Michigan, North Carolina, Oregon, Pennsylvania, Texas, and Washington. International distribution includes Australia, Austria, Belgium, Chile, Denmark, Finland, France, Germany, India, Ireland, Republic of Korea, Latvia, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, and the United Kingdom. Users should check their device serial numbers against the provided list and contact Philips for corrective action.

The recalled product

Product: EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Manufacturer: Philips Medical Systems North America Inc.
Category: Medical Device — Ultrasound System
Hazard: software-error
calculation-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

TRACE ITEM SERIAL NUMBERS in the UNITED STATES: US713B0171
US713B0207
US813B0017
US813B0018
US813B0019
US813B0020
US813B0022
US813B0023
US813B0024
US813B0025
US813B0122
US813B0123
US813B0125
US813B0127
US813B0128
US813B0129
US813B0131
US813B0132
US813B0134
US813B0135

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Same manufacturer · Philips Medical Systems North America Inc.

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Same hazard · software error