Apr

2004

Inc. Class II Spencer Technologies

Company: Spencer Technologies, Inc.
Date of Enforcement Report: 4/21/04
Class: II

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. Recall # Z-0788-04.

REASON
Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis.

CODE
Serial numbers 0001-0016, 0018-0035, 0037-0043, 0045-0048, 0050-0060, 0062-0064, 0066-0080, 0082-0157.

RECALLING FIRM/MANUFACTURER
Spencer Technologies, Inc., Seattle, WA, by letter dated February 17, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
147.

DISTRIBUTION
Nationwide and Internationally.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Inc. Class II Spencer Technologies

Amy Sellers

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