Device product
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Z-1348-2020
Product summary
- Firm
- Theralase Inc.
- Event
- Event 84842
- Status
- Terminated
- Classification
- Class III
- Quantity
- 202 units
- Official record key
device-enforcement:Z-1348-2020
Official wording
Reason: 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
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
Distribution pattern: U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Derived failure modes
-
Unknown
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