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Terminated

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

FDA Recall Z-0788-04 · Posted 2004-07-20

Recalling FirmSpencer Technologies, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2004-02-19
Date Terminated2005-01-07
Product Quantity147

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002533TCD 100M, PWD13 TRANSDUCERSpencer Technologies · 2000-08-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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