FDAFDA · Food and drugs·Recall number Z-1493-2018
Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
Published May 9, 2018 · Recall initiated: July 3, 2017
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Beijing Syntech Laser Co., Ltd
- Distributor
- US Distribution
- Lot
- Model APOLLO 1V+Medical Platform
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
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