Events

Recall of Device Recall Transcranial Doppler Ultrasound

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spencer Technologies, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28455
  • Event Risk Class
    Class 2
  • Event Number
    Z-0788-04
  • Event Initiated Date
    2004-02-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31933
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
  • Reason
    Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis.
  • Action
    Beginning on 2/19/04 the firm sent a letter dated 2/17/04 to customers via US Mail. The letter describes the malfunctions, how to avoid the malfunction and advises the customer they will be receiving a software upgrade which will resolve the problem.

Device

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
    Radiology Devices
  • 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
    Spencer Technologies, Inc.

Manufacturer

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