TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Hazard
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
What You Should Do
Remedy
Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Please courier your TLC-2000 to Theralase, at your cost, for modification. A Field Inspection Test will be completed and once passed, a Special Inspections for Medical Electrical Equipment and Systems label will be applied to your TLC-2000 Power Pack..
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Products
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
- Brand
- Theralase Inc.
- UPC
- Serial Numbers: 3104-3106 (inclusive); 3109 to 3141 (inclusive), 3143, 3146, 3147, 3155, 3158, 3159, 3163-3165 (inclusive), 3168-3173 (inclusive), 3180-3184 (inclusive), 3188-3332 (inclusive), 3334
Units Affected
202 units