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U.S. Department of Health and Human Services

Class 2 Device Recall DigniCap Delta Scalp Cooling System

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 Class 2 Device Recall DigniCap Delta Scalp Cooling Systemsee related information
Date Initiated by FirmNovember 05, 2021
Create DateMarch 24, 2022
Recall Status1 Terminated 3 on October 29, 2024
Recall NumberZ-0825-2022
Recall Event ID 89056
510(K)NumberK191166 
Product Classification Scalp cooling system - Product Code PMC
ProductDigniCap 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,
Code Information All manufactured units lots/serial numbers: A65860-A73244
Recalling Firm/
Manufacturer		 Dignitana, Inc.
10925 Estate Ln Ste W185
Dallas TX 75238-2315
For Additional Information ContactMs. Melissa Bourestom
469-518-5031
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Labeling design
ActionOn 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.
Quantity in Commerce499 dignicaps
DistributionUS Distribution to states of: LA, NC, NJ, FL, WI, CA, NY, KS, GA, SC, CT and KY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = PMC
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