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U.S. Department of Health and Human Services

Class 2 Device Recall Transcranial Doppler Ultrasound

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  Class 2 Device Recall Transcranial Doppler Ultrasound see related information
Date Initiated by Firm February 19, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on January 07, 2005
Recall Number Z-0788-04
Recall Event ID 28455
510(K)Number K002533  
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product 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
Code Information Serial numbers 0001-0016, 0018-0035, 0037-0043, 0045-0048, 0050-0060, 0062-0064, 0066-0080, 0082-0157
Recalling Firm/
Spencer Technologies, Inc.
701 16th Ave
Seattle WA 98122-4525
For Additional Information Contact Tony Williams
Manufacturer Reason
for Recall
Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis.
FDA Determined
Cause 2
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.
Quantity in Commerce 147
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = SPENCER TECHNOLOGIES