Device recall
Z-1787-2013: GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma…
FDA device recall · Class I · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-1787-2013 |
|---|---|
| Recall event | 65579 |
| Product | GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform… |
| Product code | KPS |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 19, 2014 |
| 510(k) numbers | K022960, K052434, K991841 |
| 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