Recall Z-0825-2022 ยท PMC Scalp Cooling System
Dignitana, Inc.
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 DigniCap Delta (IFU-20190327-02-EN), The DigniCap Scalp Cooling System Training Guide- Global (TR-20
| Date | Nov 5, 2021 |
| Status | Terminated |
| Reason | Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to include warnings for risk of condensation build up depending on environmental conditions with instructions. |
| Root cause | Labeling design |
| Action | On 11/05/2021, emails with subject "RE: DigniCap Delta Scalp Cooling System - Notification of Safety Updates to Instructions for Use." were sent to customers. On 02/25/2022, "URGENT: MEDICAL DEVICE CORRECTION" notices were sent to customers who were informed of the following: All patients should use a headband to prevent direct skin contact with the inner cooling cap. Depending on environmental conditions (e.g., high humidity and/or high ambient temperature) users may experience condensation that could potentially accumulate on certain components of the device such as the connectors and The |
| Quantity | 499 dignicaps |
| Distribution | US Distribution to states of: LA, NC, NJ, FL, WI, CA, NY, KS, GA, SC, CT and KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191166 | DigniCap Delta Dignitana, Inc., Jun 26, 2019 |