Z-0788-04

Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler...

Name: Z-0788-04 Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler...
Creator: Spencer Technologies, Inc.
Published: 2004-02-19
License: https://open.fda.gov/license/

Spencer Technologies / initiated 2004-02-19 / Terminated

FDA source

Spencer Technologies, Inc. began a recall of Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler... on 2004-02-19. The reason FDA records is "Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0788-04
Status: Terminated
Initiated: 2004-02-19
Posted: 2004-07-20
Terminated: 2005-01-07
Recalling firm: Spencer Technologies
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
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis.
FDA root cause: 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.
Product codes and lots: Serial numbers 0001-0016, 0018-0035, 0037-0043, 0045-0048, 0050-0060, 0062-0064, 0066-0080, 0082-0157

Product code IYN

K002533Class IITcd 100M, Pwd13 TransducerSpencer Technologies / cleared 2000-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)