Devices

Device Recall Philips Ultrasound QLAB

  • Model / Serial
    ****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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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

Manufacturer

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

One device with a similar name

Learn more about the data here

Device Recall Philips Ultrasound QLAB
  • Model / Serial
    *****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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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.