Events

Recall of Device Recall QStation Quantification Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Ultrasound, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69790
  • Event Risk Class
    Class 2
  • Event Number
    Z-0818-2015
  • Event Initiated Date
    2014-11-05
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131546
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • Reason
    When using the qlab auto 2d quantification (a2dq) and auto cardiac motion quantification (acmq) applications, the reported end-systolic volume (esv) may be smaller, and the left ventricular ejection fraction (ef) may be higher, than the esv and ef calculated by manual tracing without the use of qlab. an incorrect ef calculation could lead to misdiagnosis and/or delayed or incorrect therapy.
  • Action
    Philips has identified additional affected units and sent the Urgent-Field Safety Notice -Philips Ultrasound QLAB 10.0 (on Xcelera) letter, dated 2015/3/17, to their consignees. The FCO associated with this letter is FSN MA-FCO 83000190. The affected units identified as QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. QLAB software installed on Philips diagnostic ultrasound systems (carts) is the subject of a separate Field Safety Notice (FSN MA-FCO79500316 ). Philips has corrected this issue with QLAB version 10.2 on Xcelera and will contact customers to arrange installation of the upgrade to version 10.2 or higher free of charge. If consignees need any further information or support concerning the FCO 83000190, please contact your local Philips representative or Philips Customer Service at 1-800-722-9377. *************************************************************************************** Philips has begun sending out the URGENT - Medical Device Correction letters, dated 2014 NOV 05, for the Philips Ultrasound QLAB, Philips Model EPIQ 5 Ultrasound System, Philips Model EPIQ 7 Ultrasound System, and Philips Ultrasound Q-Station. The customer letter is also identified with the FSN # 79500316; 79500317; 79500318; or 79500321. The letters notified customers that Erroneous End-Systolic Volumes and Ejection Fraction May Be Reported When Using a2DQ & aCMQ (Auto 2D Quantification & Auto Cardiac Motion Quantification). Customers with questions should contact local Philips representative or Philips Customer Service at 1-866-767-7822.

Device

Device Recall QStation Quantification Software
  • Model / Serial
    SERIAL NUMBERS FOR FCO 79500321- Q-Station Quantification Software SYSTEM:  16B7-KADBT53D-15A9, 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, 8A9E-RAC83BE8-1583, 9811-WAD8456F-15A3, 9D79-WACD4637-158D, AAEC-MADD4FBE-15AD, ADA0-PAD7D022-15A2, B054-UAD25086-1597, B308-JACCD0EA-158C, B5BC-RAC7514E-1581, C07B-KADCDA71-15AC, C897-TACC5B9D-158B, D60A-GADC6524-15AB, D8BE-KAD6E588-15A0, DB72-RAD165EC-1595, DE26-WACBE650-158A, E0DA-XAC666B4-157F, EE4D-IAD6703B-159F, F3B5-IACB7103-1589, F669-PAC5F167-157E, H944-VACAFBB6-1589, MBF8-WAC57C1A-157E, T3DC-SAD5FAEE-159F, and Y690-GAD07B52-1594.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution (for FCO 83000190): US, including the states of AK, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, and WI; and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Germany, Ecuador, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, Norway, New Zealand, Philippines, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, and Vietnam. ********************************************************************************** Worldwide Distribution -- US, including the states of KY, TN, ME, CA, PA, NC, CT, NY, SC, IL, IN, and WI; and the countries of Argentina, Spain, India, Italy, Austria, Germany, Belgium, Canada, Finland, Switzerland, Greece, Malaysia, Sweden, Australia, Netherlands, Mexico, Peru, Taiwan, Japan, France, and Norway.
  • Product Description
    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.

Manufacturer

Philips Ultrasound, Inc.
  • Manufacturer Address
    Philips Ultrasound, Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA