Device Recall Philips Ultrasound QStation

  • Modelo / 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
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • 1 Event

Fabricante

  • Dirección del fabricante
    Philips Ultrasound, Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA