All brochures printed before November 20 recall
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information…
Why was All brochures printed before November 20 recalled?
Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site and brochures had claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, and a claim that the product could be used with a 15 mm hand piece.
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?
All brochures and online literature printed before November 20, 2013.
- Product
- All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information…
- Recalling firm
- Hyperion Medical
- Quantity
- 3,346 brochures. Quantity not applicable to web site.
- Distribution
- US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.
- Recall date
- August 27, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)