Devices

Device Recall Philips Ultrasound QLAB

  • Modèle / numéro de série
    ****SYSTEM BASED ID IN THE US***********************  12DD-14B7BC8B-295F, 25EB-143A3021-2864, 3E1D-145FC2CB-28AF,  5914-14544E46-2898, 5936-13FD3F20-27EA, 91B6-1437E5A0-285F,  9C64-1478F656-28E1, A1DD-14426F8B-2874, AC8B-14838041-28F6,  C501-13FAF49F-27E5, CCFB-144184F1-2872, and J57B-147C2B71-28E8.   *****SYSTEM BASED ID OUTSIDE THE US************************  189A-13D31774-2796, 1B4E-13CD97D8-278B, 2B31-1486400F-28FC,  2B42-145AB87C-28A5, 2E29-13D2A227-2795, 3099-147B40D7-28E6,  3B7A-1439BAD4-2863, 4BD4-13C1AE06-2773, 4E88-13BC2E6A-2768,  50E7-149054AD-2910, 512B-13E23661-27B4, 539B-148AD511-2905,  564F-14855575-28FA, 5682-1402BEBC-27F5, 5E5A-14A05E34-2930,  5E6B-1474D6A1-28D9, 611F-146F5705-28CE, 66CB-13B63981-275C,  6BCD-14B067BB-2950, 6ED6-13D14240-2792, 73E9-149FE8E7-292F,  76F2-13C0C36C-2771, 7951-1494E9AF-2919, 7C05-148F6A13-290E,  7C16-1463E280-28B7, 7C49-13E14BC7-27B2, 7C5A-13B5C434-275B,  7EA8-14B5720A-295A, 8465-13D0CCF3-2791, 8C5F-14175D45-281E,  8F35-13BACE83-2765, 91E9-13B54EE7-275A, A46F-1493FF15-2917,  B74A-1499H964-2921, C4CE-147D8B58-28EA, D798-14AE1D3A-294B,  D7A9-148295A7-28F4, DA5D-147D160B-28E9, DFB4-149D9E66-292A,  DFC5-147216D3-28D3, E268-14981ECA-291F, E7BF-14B8A725-2960,  EA95-145C1863-28A7, ED7C-13D4H20E-2797, F598-13C3833A-2776,  FDA3-13DE8BF9-27AC, and XAF4-1445A4A6-287B.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of CA, IA, KY, MD, NY, PA, UT, VA, WA and WI. Also distributed in Australia, Belgium, Canada, India, Italy, Japan, South Korea, Netherlands, New Zealand, Spain, Sweden, and Switzerland.
  • Description du dispositif
    QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
  • Manufacturer
    Philips Ultrasound, Inc.
  • 1 Event

Fabricant

Philips Ultrasound, Inc.
  • Adresse du fabricant
    Philips Ultrasound, Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA

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Device Recall Philips Ultrasound QLAB
  • Modèle / numéro de série
    *****SYSTEM BASED ID OUTSIDE THE US**********  120F-P213FA35-V41E, 279E-Q21384E8-P41D, 3FBF-X2649F25-J4BF,  47FD-Q1FD112B-J3F0, 4A8F-U24EA0B5-R493, 5570-Q20D1AB2-W410,  5D8C-G1FC9BDE-N3EF, 684B-V2122501-R41A, 6DA2-G232AD5C-S45B,  731B-Q1FC2691-V3EE, 808E-P20C3018-I40E, 88AA-T1FBB144-W3ED,  A0CB-I24CCB81-M48F, A0ED-H1F5BC5B-P3E1, AB9B-S236CD11-W463,  BE98-V1E4C83A-P3BF, C6A3-H1FFD0F9-X3F5, CBE9-M24BE0E7-Y48D,  EEFC-Y22FED8E-S455, EF0D-I20465FB-I3FE, F475-U1F966C3-X3E8, and  V49C-R203F0AE-I3FE.  ***********Two units shipped in US and one unit shipped outside the US to distributors do not have serial numbers. There are licensing agreements with these distributors that allows the distributors to create their own licensing and serial numbers and/or tracking information.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of CA, IA, KY, MD, NY, PA, UT, VA, WA and WI. Also distributed in Australia, Belgium, Canada, India, Italy, Japan, South Korea, Netherlands, New Zealand, Spain, Sweden, and Switzerland.
  • Description du dispositif
    QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
  • Manufacturer
    Philips Ultrasound, Inc.