FDAJuly 3, 2017device
Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
Official recall recorded by the U.S. Food & Drug Administration.
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 enforcement status: Ongoing
Brands named
beijing syntech laserbeijingbeijing syntech
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAFusion Pro 24, Model 170002024-08-08
- FDALeccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response ...2021-04-26
- FDALeccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).2021-04-26
- FDAClass IV New Era medical laser device2020-01-29
- FDAX-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector.2017-07-24
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