Reported Feb 26, 2020 · Terminated
TLC-2000 Therapeutic Medical Laser System
Theralase Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Theralase Inc. · 41 Hollinger Rd · East York · N/A
Is this the product you have?
- TLC-2000 Therapeutic Medical Laser System
- Lot codes and dates
- Serial Numbers3333 to 3350 (inclusive)
- Amount recalled
- 18 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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