Device recall
Z-0666-2017: Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended…
FDA device recall · Class II · Hamilton Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0666-2017 |
|---|---|
| Recall event | 75336 |
| Product | Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as… |
| Product code | CBK |
| Recalling firm | Hamilton Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2017 |
| 510(k) numbers | K122438 |
| FEI number | 2937708 |
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