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Beijing Syntech Laser Co., Ltd Recall: Beijing Syntech Laser APOLLO JV+ Medical Platform s

Beijing Syntech Laser Co., Ltd Recall: Beijing Syntech Laser APOLLO JV+ Medical Platform s is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Beijing Syntech Laser Co., Ltd; Product: Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers; Reason for recall: The noncompliance is

Recalling firmBeijing Syntech Laser Co., Ltd
ProductBeijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
Reason for recallThe 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".
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionUS Distribution
Recall initiated20170703
Recall numberZ-1493-2018
Categorydevice
StateN/A
CountryChina

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