Device recall
Z-0927-2017: MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of…
FDA device recall · Class II · Bayer Healthcare
Key facts
| Recall number (Z-number) | Z-0927-2017 |
|---|---|
| Recall event | 75736 |
| Product | MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to… |
| Product code | FRN |
| Recalling firm | Bayer Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 18, 2017 |
| FEI number | 2520313 |
At a glance
- None 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