EU alert · Safety Gate Serious risk Other - -
Laser treatment instrument AEDEN “SEMICONDUCTOR LASER TREATMENT INSTRUMENT” — risk: damage to sight
Published in the Safety Gate weekly report: · Ref. A12/1144/19
Summary
The laser beam is too powerful. Direct viewing of the laser beam could cause damage to sight.The product does not comply with the relevant European Standard EN 60825-1.
A Safety Gate alert means that national authorities found a serious or relevant risk and took measures. The same product may also be sold under other names or online.
Product
- Semiconductor laser phototherapy device. The product includes a host machine and а nasal treatment probe with a laser. Packed in a box.
What is the risk?
- The laser beam is too powerful. Direct viewing of the laser beam could cause damage to sight.The product does not comply with the relevant European Standard EN 60825-1.
Measures taken
- Type of economic operator to whom the measure(s) were ordered: RetailerCategory of measure(s): Withdrawal of the product from the market
- Date of entry into force: 21/04/2019
- Type of economic operator to whom the measure(s) were ordered: RetailerCategory of measure(s): Warning consumers of the risks
- Date of entry into force: 21/04/2019
- Type of economic operator to whom the measure(s) were ordered: RetailerCategory of measure(s): Recall of the product from end users
- Date of entry into force: 21/04/2019
Photos
Source: Safety Gate — European Commission
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