Reported Mar 4, 2020 · Terminated
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
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 · N/A
Is this the product you have?
- TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
- Lot codes and dates
- Serial Numbers
3104-3106 (inclusive)3109 to 3141 (inclusive)3143314631473155315831593163-3165 (inclusive)3168-3173 (inclusive)3180-3184 (inclusive)3188-3332 (inclusive)3334
- Serial Numbers
- Amount recalled
- 202 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards
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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