Z-0825-2022Class II

DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System...

Name: Z-0825-2022 DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System...
Creator: Dignitana, Inc.
Published: 2021-11-05
License: https://open.fda.gov/license/

Dignitana AB / initiated 2021-11-05 / Terminated / root cause: labeling and UDI

FDA source

Dignitana, Inc. began a recall of DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU... on 2021-11-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0825-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-05
Posted: 2022-03-24
Terminated: 2024-10-29
Recalling firm: Dignitana AB
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,
Product code: PMC Scalp Cooling System
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.
Root cause tag: labeling and UDI
FDA 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: [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.
Quantity in commerce: 499 dignicaps
Distribution: US Distribution to states of: LA, NC, NJ, FL, WI, CA, NY, KS, GA, SC, CT and KY.
Product codes and lots: All manufactured units lots/serial numbers: A65860-A73244

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0825-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0825-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-30	2022-03-24

Product code PMC

K191166Class IIDigniCap DeltaDignitana, Inc. / cleared 2019-06-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)