Device recall
Z-0825-2022: DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The…
FDA device recall · Class II · Dignitana, Inc.
Key facts
| Recall number (Z-number) | Z-0825-2022 |
|---|---|
| Recall event | 89056 |
| Product | DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN, Quick Reference Guide… |
| Product code | PMC |
| Recalling firm | Dignitana, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 29, 2024 |
| 510(k) numbers | K191166 |
| FEI number | 3012146457 |
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