DigniCap Delta Scalp Cooling System (PN 900-1001) recalls updated user manual for headband use and condensation risks. Affected units: Serial numbers A65860-A73244.
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.
DigniCap Delta Scalp Cooling System units (serial numbers A65860-A73244) were recalled because the user manual was updated to recommend headband use and warn about condensation risks. This update addresses safety improvements for patients undergoing scalp cooling procedures.
The updated instructions require using a headband to prevent improper application. Condensation build-up may occur in certain environmental conditions, but the recall focuses on procedural updates rather than immediate safety hazards.
Patients using the DigniCap Delta Scalp Cooling System for medical procedures are affected. Those with the specific serial numbers A65860-A73244 are most at risk.
Check the product label for serial numbers A65860 to A73244. The DigniCap Delta Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C) is part of the recalled items.
Check the user manual for the latest headband application instructions and condensation warnings.
The manufacturer updated the user manual to include headband use recommendations and warnings about condensation risks.
No, the recall involves updating instructions, not stopping use. The product remains safe with proper application.
Serial numbers A65860 to A73244.
We’ve drafted a message you can send Dignitana to request your refund or repair — edit it as you like.
Subject: Recall Z-0825-2022 — Dignitana Dignitana Hello, I own a Dignitana that is covered by recall Z-0825-2022 from Dignitana. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
