BEUDAMED
    FDA Recall Terminated

    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 Procedural Expectations- Global (TR-20191028-03-EN), DigniCap Delta Procedural Expectations TR- 20190721-02-US, DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN), DigniCap Delta Small Wrap Protocol TR-20200714-01-US, DigniCap Delta Training Tips Global (TR-20200420-04-EN), DigniCap Delta Training Tips TR-20191202-05-US,

    Recall: Z-0825-2022 · Initiated November 5, 2021

    Recall

    Recall Number
    Z-0825-2022
    Event Number
    89056
    Firm
    Dignitana, Inc.
    FEI Number
    3012146457
    Product Code
    PMC
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    November 5, 2021
    Terminated
    October 29, 2024
    Address
    10925 Estate Ln, Ste W185, Dallas, TX, 75238-2315

    Description

    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 Procedural Expectations- Global (TR-20191028-03-EN), DigniCap Delta Procedural Expectations TR- 20190721-02-US, DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN), DigniCap Delta Small Wrap Protocol TR-20200714-01-US, DigniCap Delta Training Tips Global (TR-20200420-04-EN), DigniCap Delta Training Tips TR-20191202-05-US,

    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.

    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 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: [email protected] 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 [email protected] or contact Dignitana Monday - Friday, 9:00am to 4:00pm, CST +1 877-350-2150.

    Distribution

    US Distribution to states of: LA, NC, NJ, FL, WI, CA, NY, KS, GA, SC, CT and KY.

    Quantity

    499 dignicaps