The Recall Desk
HighFDA (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.

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 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) 453
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)

  • 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 →

Related recalls

Same manufacturer · Philips Ultrasound, Inc.

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Same hazard · software error

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