The Recall Desk
ModerateFDA (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.

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. 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) 4
Manufacturer
Philips Ultrasound, Inc.
Category
Medical Device — Diagnostic Imaging
Hazard

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 →

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