Dignitana, Inc.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- Scalp Cooling SystemProduct code PMC (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4360
Recalls & enforcement
- Class IITerminated2021-11-05Instructions 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 in…
FDA inspections (1)
- VAI2024-11-05Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Dignitana, Inc. (FEI 3012146457) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012146457-dignitana-inc/
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