Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System &
FDA device recall Z-0788-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Spencer Technologies, Inc.
- Reason for recall
- Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis.
- Action taken
- 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
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 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.
- Date initiated
- 2004-02-19
- Date posted
- 2004-07-20
- Date terminated
- 2005-01-07
- Location
- Seattle, WA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TCD 100M, PWD13 TRANSDUCER (K002533) | Spencer Technologies | 2000-08-30 |