Device recall
Z-0788-04: Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital…
FDA device recall · Class II · Spencer Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-0788-04 |
|---|---|
| Recall event | 28455 |
| 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… |
| Product code | IYN |
| Recalling firm | Spencer Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 7, 2005 |
| 510(k) numbers | K002533 |
| FEI number | 3003139439 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database