CLASS III Device recall · Reported 4 Mar 2020 · FDA Enforcement Report

TLC-2000 Therapeutic Medical Laser System Power Pack recalled

Theralase is recalling TLC-2000 Therapeutic Medical Laser System Power Pack. The recall was initiated on 26 Sep 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled202 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1348-2020
FDA event ID: 84842
Recalling firm: Theralase, East York, N/A
Classification: Class III
Status: Terminated
Recall initiated: 26 Sep 2019
FDA classified: 24 Feb 2020
Reported: 4 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

26 Sep 2019	Recall initiated by company
24 Feb 2020	Classified by FDA	+151 days
4 Mar 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Theralase

All 7

Reported	Class	Recall	Company	Reason	Where
4 Mar 2020Device	CLASS III	TLC-2000 Therapeutic Medical Laser System recalled by Theralase	Theralase	Other	N/A
4 Mar 2020Device	CLASS III	TLC-2000 Therapeutic Medical Laser System recalled by Theralase	Theralase	Other	N/A
26 Feb 2020Device	CLASS III	TLC-2000 Therapeutic Medical Laser System recalled by Theralase	Theralase	Other
26 Feb 2020Device	CLASS III	TLC-2000 Therapeutic Medical Laser System recalled by Theralase	Theralase	Other	Nationwide
11 Dec 2019Device	CLASS III	Tlc-2000 Therapeutic Medical Laser System recalled by Theralase	Theralase	Other	Nationwide

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