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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84842

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 26, 2019
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Theralase Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1348-2020
Recall number
Z-1348-2020
Initiated
September 26, 2019
Classification
Class III
Status
Terminated
Recalling firm
Theralase Inc.
Quantity
202 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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

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