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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95642

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

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Event summary

Timeline bucket
October 28, 2024
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Remote Diagnostic Technologies Ltd.

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

Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode

Z-0557-2025
Recall number
Z-0557-2025
Initiated
October 28, 2024
Classification
Class III
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrect labels

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

Code information

Model Number: 00-3020 UDI-DI code: 07613365002737 Serial Numbers: 7022.000367 7022.000387 7022.000392 7022.000462 7022.000463 7022.000464 7022.000559 7022.000591 7022.000595 7022.000711 7022.000781 7022.000786 7022.00108 7022.001175 7022.001201 7022.00129 7022.001556 7022.001582

Distribution pattern

U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.

Field note

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