Solea 1.0 Laser Surgical instrument for use in general recall
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Why was Solea 1.0 Laser Surgical instrument for use in general recalled?
Specific error condition could lead to unintended laser emission during laser activation.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: CDS1-DVSU-1B-JU-13; CDS1-7QRE-1B-JU-13; CDS1-22TZ-1B-JU-13; CDS1-PNJZ-1B-AU-13; CDS1-A4CQ-1B-AU-13
- Product
- Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
- Recalling firm
- Convergent Dental
- Quantity
- 5
- Distribution
- US distribution including states of: MA, CT, NY.
- Recall date
- October 30, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)