Device recall
Z-2062-2011: S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is…
FDA device recall · Class II · Philips Medical Systems Nederlands
Key facts
| Recall number (Z-number) | Z-2062-2011 |
|---|---|
| Recall event | 58320 |
| Product | S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471. The User information is labeled in part: "***iE33 Ultrasound System ***User Information Update***4535 614 04811 Rev A***New S8-3t TEE Transducer*** This release of the iE33 Ultrasound System supports the S8-3t… |
| Product code | IYN |
| Recalling firm | Philips Medical Systems Nederlands |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 14, 2012 |
| 510(k) numbers | K030455 |
| FEI number | 3002807880 |
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