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.
What this means for you
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.
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
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