Device Recall Transcranial Doppler Ultrasound

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

Radiology Devices

2

No

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.

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