Solta Medical Recalls Fraxel DUAL Laser Systems Due to Incorrect Labeling
Solta Medical is recalling 1,077 Fraxel DUAL 1550/1927 Laser Systems because obsolete treatment cards may contain incorrect indications for treating Melasma.
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: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error (incorrect indication for use) without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
Solta Medical, Inc. is recalling 1,077 units of the FRAXEL DUAL 1550/1927 Laser System (also known as the FRAXEL SR 1500 DUAL Laser System). The affected devices are Model MC-SYS-SR1500-D, Revisions A and B, which were distributed worldwide for dermatological procedures.
The recall was initiated because obsolete versions of the Laser Treatment Settings card included with these systems may have contained incorrect indications for use regarding the treatment of Melasma. This labeling error could potentially lead to improper use of the device for this specific condition.
Healthcare providers and consumers who possess these specific model and revision numbers should stop using the affected treatment cards and contact Solta Medical for further instructions or replacement materials.
The recalled product
- Product
- FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
- Manufacturer
- Solta Medical, Inc.
- Category
- Medical Device — Laser System
- Hazard
- Affected units
- 1,077
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 (2)
- Model MC-SYS-SR1500-D
- Revisions A and B.
Distribution
Distribution scope not specified by the agency.
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