The Recall Desk
ModerateFDA (Devices)·Z-2110-2014·Announced 2014-07-30

Philips QLAB 10.1 Software Recalled for Incorrect Measurement Defect

Philips Ultrasound is recalling QLAB 10.1 software because a defect may cause incorrect measurement values under specific conditions.

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, and the defect involves incorrect measurement values without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Philips Ultrasound, Inc. is recalling the QLAB 10.1 Core Module (PN 453561728001). 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. A total of 59 units are affected, with 12 units in the United States and 47 units outside the United States.

In the United States, the software was distributed in California, Iowa, Kentucky, Maryland, New York, Pennsylvania, Utah, Virginia, Washington, and Wisconsin. It was also distributed in Australia, Belgium, Canada, India, Italy, Japan, South Korea, the Netherlands, New Zealand, Spain, Sweden, and Switzerland. Users should contact Philips Ultrasound for further instructions on correcting the defect.

The recalled product

Product
QLAB 10.1 Core Module PN 453561728001. 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 IN THE US*********************** 12DD-14B7BC8B-295F
  • 25EB-143A3021-2864
  • 3E1D-145FC2CB-28AF
  • 5914-14544E46-2898
  • 5936-13FD3F20-27EA
  • 91B6-1437E5A0-285F
  • 9C64-1478F656-28E1
  • A1DD-14426F8B-2874
  • AC8B-14838041-28F6
  • C501-13FAF49F-27E5
  • CCFB-144184F1-2872
  • 1B4E-13CD97D8-278B
  • 2B31-1486400F-28FC
  • 2B42-145AB87C-28A5
  • 2E29-13D2A227-2795
  • 3099-147B40D7-28E6
  • 3B7A-1439BAD4-2863
  • 4BD4-13C1AE06-2773
  • 4E88-13BC2E6A-2768
  • 50E7-149054AD-2910

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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