Device recall
Z-2958-2018: Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-2958-2018 |
|---|---|
| Recall event | 80804 |
| Product | Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319 |
| Product code | OLW |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K072286 |
| FEI number | 1219930 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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