Z-1348-2020Class III

TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002

Name: Z-1348-2020 TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Creator: Theralase Inc.
Published: 2019-09-26
License: https://open.fda.gov/license/

Theralase Technologies Inc. / initiated 2019-09-26 / Terminated / root cause: manufacturing process

FDA source

Theralase Inc. began a recall of TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 on 2019-09-26. FDA classified it as Class III and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1348-2020
Classification: Class III
Status: Terminated
Initiated: 2019-09-26
Posted: 2020-02-13
Terminated: 2020-12-03
Recalling firm: Theralase Technologies Inc.
Product: TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Product code: NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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..
Quantity in commerce: 202 units
Distribution: U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1348-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1348-2020	Class III	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-24

Product code NHN

K151816Class IITLC-2000 Therapeutic Medical Laser SystemTheralase, Inc. / cleared 2015-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)