Z-1348-2020 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2020
- Initiation Date
- September 26, 2019
- Termination Date
- December 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 202 units
Product Description
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Reason for Recall
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
Distribution Pattern
U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Code Information
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