Device Recall Transcranial Doppler Ultrasound

  • Model / Serial
    Serial numbers 0001-0016, 0018-0035, 0037-0043, 0045-0048, 0050-0060, 0062-0064, 0066-0080, 0082-0157
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed to 91 end users (hospitals, medical centers) and 2 distributors throughout the US. Foreign distribution included 3 distributors and 14 end users.
  • Product Description
    Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler Ultrasound System (these systems are the same hardware and software - the change from TCD 100M to PMD 100 is a marketing change). Software version 1.3.0 || Model numbers 10119, 10863, 10919, 10968, 11016, 11052, 11090, 11091, 11235, 11236
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Spencer Technologies, Inc., 701 16th Ave, Seattle WA 98122-4525
  • Source
    USFDA