Food, drugs, devices › Theralase Inc.
Device recall: TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
FDA enforcement event 84842 is a device recall by Theralase Inc. of East York, N/A, initiated 26 Sep 2019 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 6% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 3 Dec 2020. Initiation: voluntary: firm initiated. Theralase Inc. has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Theralase Inc., East York, N/A, Canada.
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
"U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1348-2020 | TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 | 202 units | Class III | Terminated | 4 Mar 2020 |
Context
Other enforcement events for Theralase Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 26 Sep 2019 | TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain. | Device | Class III | 1 |
| 26 Sep 2019 | TLC-2000 Therapeutic Medical Laser System | Device | Class III | 1 |
| 26 Sep 2019 | TLC-2000 Therapeutic Medical Laser System | Device | Class III | 1 |
| 26 Sep 2019 | TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain. | Device | Class III | 2 |
| 26 Sep 2019 | TLC-2000 Therapeutic Medical Laser System | Device | Class III | 1 |
All 6 events for Theralase Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Dec 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.