CLASS II ONGOING Device recall · Reported 9 May 2018 · FDA Enforcement Report
Diode Laser surgical lasers recalled by Beijing Syntech Laser Co
Beijing Syntech Laser Co is recalling Beijing Syntech Laser Diode Laser surgical lasers. The recall was initiated on 3 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1488-2018
- FDA event ID
- 79697
- Recalling firm
- Beijing Syntech Laser Co, Beijing, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jul 2017
- FDA classified
- 2 May 2018
- Reported
- 9 May 2018
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Surgical Instruments
Timeline
| 3 Jul 2017 | Recall initiated by company | |
| 2 May 2018 | Classified by FDA | +303 days |
| 9 May 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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".
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
Beijing Syntech Laser Diode Laser surgical lasers
Where it was distributed
US Distribution
Questions about this recall
Is Diode Laser surgical lasers recalled?
Yes. Beijing Syntech Laser Co recalled Diode Laser surgical lasers on 3 Jul 2017. The recall is Class II and its status is Ongoing. Recall number Z-1488-2018.
Why was it recalled?
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".
Which lots are affected?
Model Diode Laser
Where was it sold?
US Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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