DermaSensor recalled 343 diagnostic devices on October 13, 2025, due to a risk of incorrect results. The recall affects nine units specifically identified for failing to meet specifications. This issue could delay patient referrals for necessary treatment.
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact DERMASENSOR INC or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The recalled product is the DermaSensor, Model 10101, Software Version 3.0.2. It was distributed to multiple U.S. states including Florida, Arizona, and California.
The device may not meet required specifications, leading to incorrect diagnostic results. This can potentially delay referrals for patients with suspicious skin lesions.
Currently, no injuries or deaths have been reported as a result of this defect. The recall affects nine specific units of the total 343 distributed.
Cease use of the DermaSensor immediately. Follow recall instructions from the manufacturer and contact DERMASENSOR INC or your healthcare provider for guidance.
For more information, contact DERMASENSOR INC at the phone number listed on their website. You can also visit the FDA recall page for detailed instructions.
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