Beijing Syntech Laser Diode Laser surgical lasers recall
Beijing Syntech Laser Diode Laser surgical lasers
Why was Beijing Syntech Laser Diode Laser surgical lasers recalled?
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Model Diode Laser
- Product
- Beijing Syntech Laser Diode Laser surgical lasers
- Recalling firm
- Beijing Syntech Laser Co., Ltd
- Quantity
- 13
- Distribution
- US Distribution
- Recall date
- May 9, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)