Events

Recall of Device Recall Philips Ultrasound QStation

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
    71432
  • Event Risk Class
    Class 2
  • Event Number
    Z-1807-2015
  • Event Initiated Date
    2015-05-15
  • Event Date Posted
    2015-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137745
  • 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
    Philips healthcare has discovered a problem in the philips ultrasound q-station version 3.0 or higher that could result in measurements from a study (structured report) to be appended to subsequent studies for other patients.
  • Action
    PhilipsHealthcare sent an URGENT - Medical Device Correction Philips Ultrasound Q-Station, Q-STATION STRUCTURED REPORTING AND MEASUREMENTS letter, FCO 79500335, dated 2015 May 15, to all affected consignees. Philips is sending a CD with Q-Station software version 3.3.2 to consignees for a free of charge. Consignees must uninstall previous versions of Q-Station and install version 3.3.2 on your system carefully following the installation instructions that accompany the CD. It is important that consignees register their Q Station 3.3.2 installation as described in those instructions, so that Philips can confirm that they have completed this correction. Consignees were instructed to complete the enclosed Customer Reply Form to confirm that they have (1) read and understood this important Medical Device Correction and (2) have either installed Q-Station version 3.3.2 or declare that this FCO 79500335 does not apply to their institution. Consignees were asked to return the enclosed Customer Reply form to Philips Healthcare within 5 days of receipt of the replacement software. Consignees with questions can call local Philips representative or Philips Customer Service at 1-800-722-9377.

Device

Device Recall Philips Ultrasound QStation
  • Model / Serial
    *****************US Serial numbers*****************************************  2176-IAF08E60-15D4, 2187-VAC5T6CD-157D, 2C98-25A23E3A-4B2E,  34F5-4084F543-80EA, 3A5D-4079F60B-80D4, 54B0-HADF24F2-15B1,  678B-NAE42F41-15BB, 6FF9-259B5EB7-4B20, 725B-GACE30D1-158F,  72EE-408914F8-80F2, 7A39-497627F7-92C9, 8536-IAD33B20-1599,  A584-QAE84EF6-15C3, A838-IAE2CF5A-15B8, B903-407CB5D9-80D9,  BDC7-TAE25A0D-15B7, D356-YAE1E4C0-15B6, D60A-GADC6524-15AB,  D8BE-KAD6E588-15A0, DB72-RAD165EC-1595, DE26-WACBE650-158A,  E0DA-XAC666B4-157F, E16D-40814ADB-80E2, E8E5-TAE16F73-15B5,  EE4D-IAD6703B-159F, F669-PAC5F167-157E, F90C-MAEBF95E-15CA,  H944-VACAFBB6-1589, MBF8-WAC57C1A-157E, U9D7-4085DFDD-80EC.   ********************Serial numbers in CANADA****************************************  1ED3-QACA8669-1588, 4489-SAD49B07-159C, B054-UAD25086-1597,  C897-TACC5B9D-158B, and F3B5-IACB7103-1589.    *********************Serial numbers in other countries***********************************  114F-QAE6M475-15BF, 11F3-40756109-80CB, 16B7-KADBT53D-15A9,  196B-UAD585A1-159E, 1F66-40856A90-80EB, 221A-407FEAF4-80E0,  23FD-4977FD2B-92CD, 242A-MAEBPEC4-15C9, 24CE-407A6B58-80D5,  2782-4074EBBC-80CA, 2965-496CFDF3-92B7, 29E4-25A7BDD6-4B39,  2C46-QADA8FF0-15A8, 2EFA-RAD51054-159D, 2F4C-259CBE9E-4B23,  3716-IAC49180-157C, 37A9-407F75A7-80DF, 3C6D-XAE519DB-15BD,  3CBF-25ACC825-4B43, 3D11-4074766F-80C9, 41D5-NADA1AA3-15A7,  47D0-4089FF92-80F4, 49F1-IAC99BCF-1586, 4C94-YAEFA3C6-15D2,  4CA5-UAC41C33-157B, 4F1B-49771291-92CB, 4FEC-407980BE-80D3,  524E-25AC52D8-4B42, 5764-MAD9A556-15A6, 5A18-QAD425BA-159B,  5CCC-HACEA61E-1590, 5F80-MAC92682-1585, 6013-4084IAA9-80E8,  61F6-497C1CE0-92D5, 62C7-407E8B0D-80DD, 657B-4079TB71-80D2,  6CF3-WAD93009-15A5, 750F-TAC8B135-1584, 75A2-4083955C-80E7,  7856-407E15C0-80DC, 7B0A-40789624-80D1, 7CED-4970A85B-92BE,  7D6C-25AB683E-4B40, 7FCE-HADE3A58-15AF, 8282-JAD8BABC-15A4,  87EA-PACDBB84-158E, 8A9E-RAC83BE8-1583, 8B31-4083200F-80E6,  8D14-497B3246-92D3, 8D41-NAEE43DF-15CF, 8DE5-407DA073-80DB,  8FF5-NAE8C443-15C4, 9099-407820D7-80D0, 9811-WAD8456F-15A3,  9D79-WACD4637-158D, A0C0-4082AAC2-80E5, A374-407D2B26-80DA,  A628-4077AB8A-80CF, A80B-496FBDC1-92BC, AAEC-MADD4FBE-15AD,  ADA0-PAD7D022-15A2, B308-JACCD0EA-158C, B39B-4087B511-80EF,  B5BC-RAC7514E-1581, B64F-40823575-80E4, B832-497A47AC-92D1,  B85F-UAED5945-15CD, BAE6-4974C810-92C6, BBB7-4077363D-80CE,  BE19-25AAH857-4B3D, C07B-KADCDA71-15AC, CBDE-4081C028-80E3,  CDC1-4979D25F-92D0, CE92-407C408C-80D8, D146-4076C0F0-80CD,  E37D-JAEC6EAB-15CB, E421-407BCB3F-80D7, F448-4086552A-80EC,  F6FC-4080D58E-80E1, F8DF-4978E7C5-92CE, F9B0-407B55F2-80D6,  FC64-4075D656-80CB, T3DC-SAD5FAEE-159F, TF3F-407AE0A5-80D6,  VC8B-40806041-80E1, and Y690-GAD07B52-1594.   **********NEWLY ADDED FOUR AFFECTED SERIAL NUMBERS******* aaec-madd4fbe-15ad; WE9B-QAEB8411-15CA; 2B14-MDE9A2F9-1BC6; and 3C40-4972P842-92C1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Puerto Rico; internationally to Australia, Canada, Colombia, France, Germany, Great Britain, India, Italy, Mexico, Netherlands, Norway, Pakistan, Poland, Russia, Singapore, Spain, Switzerland, Thailand, and Zimbabwe.
  • Product Description
    Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 || Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provide integrated tools that allow users to manually assess and score cardiac wall motion and export images and / or exams and reports. Q-Station can view DICOM images of non-ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT and X-Ray modalities for reference viewing. It support connectivity to ultrasound systems, PACS and other DICOM storage repositories.
  • 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