Recall Z-0788-04 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Spencer Technologies, Inc.
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
| Date | Jul 20, 2004 (initiated Feb 19, 2004) |
| Status | Terminated |
| Reason | Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002533 | TCD 100M, PWD13 TRANSDUCER Spencer Technologies, Aug 30, 2000 |