The Recall Desk
HighFDA (Devices)·Z-1578-2015·Announced 2015-05-13

Philips EPIQ 5 Ultrasound Systems Recalled for Pediatric BSA Calculation Error

Philips is recalling EPIQ 5 Ultrasound Systems with the Pediatric Cardiology option because a unit conversion error may cause incorrect Body Surface Area calculations.

What this means for you

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 may 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 equipped with the Pediatric Cardiology option. The affected models include EPIQ 5G, EPIC 5C, and EPIQ 5W, with catalog numbers 795204 and 795205.

The recall is due to a unit conversion error that may occur when the system is set to Metric and weight and/or height is entered. This error can result in the incorrect calculation of a patient's Body Surface Area (BSA). A total of 751 units are affected, with 246 units in the United States and 505 units distributed internationally to countries including Norway, India, New Zealand, Bahrain, Sweden, Italy, Australia, France, Netherlands, Switzerland, Germany, Austria, and Turkey.

Healthcare providers should identify affected units by checking the system codes listed in the official recall notice. Users should contact Philips Ultrasound for instructions on how to resolve the issue.

The recalled product

Product
EPIQ 5 Ultrasound System with 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) 453561772611 (1.2.1) 453561786571 (1
Manufacturer
Philips Ultrasound, Inc.
Category
Medical Device — Ultrasound System
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)

  • US114C0206
  • US114C0210
  • US114C0239
  • US114C0240
  • US114C0241
  • US114C0271
  • US114C0272
  • US114C0273
  • US114C0286
  • US114C0321
  • US114C0322
  • US114C0331
  • US114C0332
  • US114C0333
  • US114C0334
  • US114C0444
  • US114C0534
  • US114C0605
  • US114C0674
  • US115C0140

Distribution

Distributed nationwide across the United States.

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 →

Related recalls

Same manufacturer · Philips Ultrasound, Inc.

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Same hazard · calculation error

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