Agency classClass IIOur severity:High FDA (Devices)·Z-1631-2015·Announced 2015-05-27

Philips EPIQ 5 Ultrasound System Recalled for Body Surface Area Calculation Error

Philips is recalling EPIQ 5 Ultrasound Systems due to a unit conversion error that may cause incorrect Body Surface Area calculations when using Metric settings.

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 involves a medical device defect that could lead to incorrect clinical calculations (BSA), which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Philips Ultrasound, Inc. is recalling EPIQ 5 Ultrasound Systems (Models EPIQ 5G, EPIC 5C, EPIQ 5W) running software versions 1.3.2 or lower that do not include the Pediatric Cardiology option. The recall involves 1,108 units distributed worldwide, including 490 units in the United States.

The recall is due to a unit conversion error that occurs when the system is set to "Metric" and patient weight and/or height are entered. This error may result in the incorrect display of these values and the incorrect calculation of the patient's Body Surface Area (BSA). No injuries or illnesses have been reported in connection with this defect.

Healthcare providers should contact Philips Ultrasound for instructions on how to resolve the issue. Consumers and patients should consult their healthcare providers regarding any diagnostic results obtained using the affected systems.

The recalled product

Product: EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2)…
Manufacturer: Philips Ultrasound, Inc.
Category: Medical Device — Diagnostic Imaging
Hazard: software-error
incorrect-calculation

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)

US114C0208
US114C0209
US114C0287
US114C0308
US114C0323
US114C0330
US114C0445
US114C0713
US114C0714
US114C0731
US115C0139
US115C0464
US115C0465
US115C0470
US115C0471
US115C0537
US115C0538
US115C0539
US115C0576
US115C0607

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Philips Ultrasound, 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 Ultrasound, Inc.

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