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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/
Manufacturer		 Spencer Technologies, Inc.
701 16th Ave
Seattle WA 98122-4525
For Additional Information Contact Tony Williams
206-329-7220
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		 Other
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
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