FDA Medical Device Recalls (openFDA)
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-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 number
- Z-0825-2022
- Recalling firm
- Dignitana, Inc.
- 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 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,
- Status
- Terminated
- Initiated
- 2021-11-05
- Posted
- not on file
- Terminated
- 2024-10-29
- 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 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
- 499 dignicaps
- Distribution
- US Distribution to states of: LA, NC, NJ, FL, WI, CA, NY, KS, GA, SC, CT and KY.
- Lot, serial or model codes
- All manufactured units lots/serial numbers: A65860-A73244
- 510(k) numbers
- ["K191166"]
- PMA numbers
- not on file
- Product code
- PMC
- Firm FEI
- 3012146457
- Firm city
- Dallas
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28