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-20200104-05-EN), The DigniCap Scalp Cooling System Training Guide TR-2019-0801-05-US, DigniCap Delta P

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 Therapy Hose. This condensation may transfer to the area around the device potentially creating a "Wet floor" condition which could lead to injury from slipping and/or falling. Wipe down the device and any wet components, during or after treatment, as needed at any point in time to avoid hazardous situations. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: 1. Immediately start using updated instructions amended in this letter. This is a long term and permanent change. 2. Retrain staff to ensure that the headband is used correctly for every treatment. 3. Retrain staff that any condensation on the device should be wiped down before, during and after use 4. Amend the appropriate section of the DigniCap User Manual with the corrections attached to this letter. An electronic copy of the updated User Manual will be emailed to you by March 15, 2022. 5. For orders placed after March 15, 2022, labeling on Affected Guides detailed below will include corrected IFUs. Complete and return the acknowledgment and response form to: Email: qualityaffairs@dignitana.com Postal mail: Dignitana, 10925 Estate Lane W-185, Dallas, TX 75238 USA Dignitana, Traktorgrnden 3, 226 60 Lund, Sweden If you have questions regarding any of the above information, please email support@dignicap.com or contact Dignitana Monday - Friday, 9:00am to 4:00pm, CST +1 877-350-2150.