Device recall
Z-2895-2018: Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066…
FDA device recall · Class II · Philips Electronics North America Corporation
Key facts
| Recall number (Z-number) | Z-2895-2018 |
|---|---|
| Recall event | 80645 |
| Product | Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of… |
| Product code | MHX |
| Recalling firm | Philips Electronics North America Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K080495, K123900 |
| FEI number | 1218950 |
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