Skin cancer aid recalled because it may not meet specifications
DermaSensor is recalling nine affected units of its software-aided diagnostic device because it may not meet specifications, risking incorrect results or a delayed referral.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: incorrect results or a delayed skin cancer referral is a hazard, and no injuries are reported.
Plain-English summary
The DermaSensor, model 10101, software version 3.0.2, a software-aided adjunctive diagnostic device used by physicians on lesions suspicious for skin cancer, is being recalled.
The firm identifies the potential for the device to not meet specifications, resulting in incorrect results or delay of referral for patients.
The record lists 343 units with 9 units affected, carrying UDI-DI 085001778610101A9 and identified by serial number. The product was distributed in Maryland, Florida, Arizona, Mississippi, Pennsylvania, New York, Connecticut and California. The FDA has classified the action as Class II.
A device used to assess lesions for skin cancer influences whether a patient is referred on. The enforcement record reports no injuries. Practices holding an affected serial number should follow the firm's instructions.
The recalled product
- Product
- DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
- Manufacturer
- DERMASENSOR INC
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 (11)
- Lot Code: Model No 10101
- UDI-DI 085001778610101A9
- Serial Number 1010120241230196E4E
- 1010120241240151FD5
- 101012024130014EF69
- 101012024125014F595
- 10101202413001F7C66
- 1010120242400172717
- 101012024325014CE26
- 10101202433101D295C
- 101012025093012EE03.
Distribution
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