Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1632-2015·Announced 2015-05-27

Philips EPIQ 7 Ultrasound System Recalled for Unit Conversion Error

Philips is recalling EPIQ 7 Ultrasound Systems due to a unit conversion error that may cause incorrect Body Surface Area calculations.

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. The hazard involves incorrect data calculation (BSA) rather than a direct physical injury mechanism, and no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Philips Ultrasound, Inc. is recalling EPIQ 7 Ultrasound Systems, specifically versions 1.3.2 or lower that do not include the Pediatric Cardiology option. The affected models include EPIQ 7G, EPIC 7C, and EPIQ 7W.

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).

A total of 1,692 units are affected, with 902 units in the United States and 790 units outside the United States. The products were distributed worldwide. Users should check their system base ID against the list provided in the official recall notice to determine if their device is affected.

The recalled product

Product: EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1)…
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)

US114B0057
US114B0160
US114B0187
US114B0188
US114B0189
US114B0224
US114B0282
US114B0283
US114B0303
US114B0318
US114B0355
US114B0393
US114B0394
US114B0400
US114B0401
US114B0403
US114B0435
US114B0468
US114B0495
US114B0527

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.

See all →

Low
Philips 3D6-2 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
Low
Philips S4-1 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
Low
Philips X7-2 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
Low
Philips C9-4 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
Low
Philips OMNI III TEE transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01

Same hazard · software error