DigniCap Delta Scalp Cooling System instructions updated for headband use
Dignitana updated instructions for the DigniCap Delta Scalp Cooling System to recommend headband use and warn about condensation risk in certain environmental conditions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall with no reported illnesses or injuries. The issue involves precautionary updates to Instructions for Use regarding headband application and warnings about potential condensation buildup—an instructional matter rather than a product defect causing reported harm.
Plain-English summary
The DigniCap Delta Scalp Cooling System (Product Number 900-1001) is a medical device used to reduce hair loss during cancer chemotherapy. Instructions for Use (IFUs) for this device have been updated by manufacturer Dignitana, Inc.
The updated instructions now recommend headband use for all patients and include guidance on proper headband application. Additionally, the IFUs have been revised to include warnings about the risk of condensation buildup depending on environmental conditions, along with instructions to address this risk.
Approximately 499 units of the DigniCap Delta Scalp Cooling System have been distributed across the United States, including to Louisiana, North Carolina, New Jersey, Florida, Wisconsin, California, New York, Kansas, Georgia, South Carolina, Connecticut, and Kentucky.
Users and healthcare providers should review the updated Instructions for Use, which contain important information about proper use of the headband and environmental conditions that may affect device operation.
The recalled product
- 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…
- Manufacturer
- Dignitana, Inc.
- Affected units
- 499
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All manufactured units lots/serial numbers: A65860-A73244
Distribution
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