Theralase TLC-2000 Laser Power Pack Recalled for Battery Testing Deficiency
Theralase Inc. is recalling 202 TLC-2000 Therapeutic Medical Laser System Power Packs because the internal battery pack was not tested to IEC-60601-1-2 standards.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation and testing standard deficiency rather than a direct physical hazard like fire or shock.
Plain-English summary
Theralase Inc. is recalling 202 units of the TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002. The recall involves specific serial numbers ranging from 3104 to 3334, with exclusions for certain numbers within that range. The affected units were distributed in the U.S.A. and several international locations, including Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, and Romania.
The recall was initiated because the internal battery pack shipped with the power pack was tested to UN-38.3, UL-2054, and IEC-62133 (2nd Edition) standards, but was not tested to IEC-60601-1-2 (3rd edition) standards. This deficiency relates to the electromagnetic compatibility testing required for medical electrical equipment.
Consumers and healthcare providers who possess these specific power packs should stop using them and contact Theralase Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
- Manufacturer
- Theralase Inc.
- Category
- Medical Device — Laser Therapy
- Hazard
- Affected units
- 202
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 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
Distribution scope not specified by the agency.
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