Device recall
Z-2219-2009: GE Healthcare Ventri, GE Healthcare, Waukesha, WI. Model number(s): H3000YW…
FDA device recall · Class II · GE Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-2219-2009 |
|---|---|
| Recall event | 51309 |
| Product | GE Healthcare Ventri, GE Healthcare, Waukesha, WI. Model number(s): H3000YW, H3000YY, H3000ZW, H3000YT. The intended use of the VENTRi system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes. |
| Product code | KPS |
| Recalling firm | GE Medical Systems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 12, 2012 |
| 510(k) numbers | K051855 |
| FEI number | 2126677 |
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