The Recall Desk
HighFDA (Devices)·Z-2109-2014·Announced 2014-07-30

Philips QLAB 10 Core Module Software Recall for Measurement Defect

Philips Ultrasound is recalling QLAB 10 Core Module software due to a defect that may use incorrect measurement values under specific conditions.

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 software defect that may result in incorrect measurement values, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Philips Ultrasound, Inc. is recalling the QLAB 10 Core Module software (PN 453561704771). This software application is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.

The recall is due to a defect in the QLAB a2DQ and aCMQ features that may use incorrect measurement values under specific conditions. The recall involves 25 units total, with 2 units in the US and 23 units outside the US. The software was distributed in the states of CA, IA, KY, MD, NY, PA, UT, VA, WA, and WI, as well as in Australia, Belgium, Canada, India, Italy, Japan, South Korea, Netherlands, New Zealand, Spain, Sweden, and Switzerland.

Users of the affected software should contact Philips Ultrasound for further instructions regarding the defect and potential corrective actions.

The recalled product

Product
QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
Manufacturer
Philips Ultrasound, Inc.
Category
Medical Device — Ultrasound Software
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)

  • *****SYSTEM BASED ID OUTSIDE THE US********** 120F-P213FA35-V41E
  • 279E-Q21384E8-P41D
  • 3FBF-X2649F25-J4BF
  • 47FD-Q1FD112B-J3F0
  • 4A8F-U24EA0B5-R493
  • 5570-Q20D1AB2-W410
  • 5D8C-G1FC9BDE-N3EF
  • 684B-V2122501-R41A
  • 6DA2-G232AD5C-S45B
  • 731B-Q1FC2691-V3EE
  • 808E-P20C3018-I40E
  • 88AA-T1FBB144-W3ED
  • A0CB-I24CCB81-M48F
  • A0ED-H1F5BC5B-P3E1
  • AB9B-S236CD11-W463
  • BE98-V1E4C83A-P3BF
  • C6A3-H1FFD0F9-X3F5
  • CBE9-M24BE0E7-Y48D
  • EEFC-Y22FED8E-S455
  • EF0D-I20465FB-I3FE

Distribution

Distributed in 10 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 · incorrect measurement

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