The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0818-2015·Announced 2014-12-24

Philips Q-Station Software Recalled for Potential Incorrect Cardiac Measurements

Philips is recalling Q-Station 3.0 software because automated cardiac measurements may be inaccurate, potentially leading to misdiagnosis or incorrect therapy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 could lead to misdiagnosis or incorrect therapy, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Ultrasound, Inc. is recalling Q-Station Quantification Software, specifically Q-Station 3.0 equipped with a2DQ and/or aCMQ Q-Apps. The software is intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. The recall affects 43 units, with 13 located in the United States and 30 outside the US.

The recall is due to a defect where the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than values calculated by manual tracing. An incorrect EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy.

The affected software was distributed worldwide, including in the United States and numerous international countries. Users should contact Philips Ultrasound for further instructions on how to address the software defect.

The recalled product

Product
Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams.
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)

  • 196B-UAD585A1-159E
  • 1ED3-QACA8669-1588
  • 2187-VAC5T6CD-157D
  • 2C46-QADA8FF0-15A8
  • 2EFA-RAD51054-159D
  • 3716-IAC49180-157C
  • 41D5-NADA1AA3-15A7
  • 4489-SAD49B07-159C
  • 49F1-IAC99BCF-1586
  • 4CA5-UAC41C33-157B
  • 5764-MAD9A556-15A6
  • 5A18-QAD425BA-159B
  • 5CCC-HACEA61E-1590
  • 5F80-MAC92682-1585
  • 6CF3-WAD93009-15A5
  • 725B-GACE30D1-158F
  • 750F-TAC8B135-1584
  • 8282-JAD8BABC-15A4
  • 8536-IAD33B20-1599
  • 87EA-PACDBB84-158E

Distribution

Distributed in 32 states:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · Philips Ultrasound, Inc.

See all →

Same hazard · misdiagnosis

See all →

Similar recalls