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
  • 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
  • 1 Event

Manufacturer

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