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.
