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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83576

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

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Event summary

Timeline bucket
July 16, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips North America, LLC

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

HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual operation allows users to select energy levels for external and internal defibrillation. Users may also perform synchronized cardioversion. Non-invasive external pacing is a device option. In AED mode, the HeartStart MRx allows the provider who is trained in Basic Life Support (BLS) to provide defibrillation therapy. The device analyzes a patient s rhythm and advises the user to deliver a shock. Voice prompts guide the user through the defibrillation process by providing instructions and patient information. The voice prompts are reinforced by messages that appear on the display. In both modes of operation, the HeartStart MRx utilizes impedance compensating biphasic truncated exponential therapy waveform. The HeartStart MRx can also be used for ECG monitoring of a patient using 3, 5 or 12 lead cables.

Z-2488-2019
Recall number
Z-2488-2019
Initiated
July 16, 2019
Classification
Class II
Status
Terminated
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.

Code information

Lot/ Serial # US00539461, US00539462

Distribution pattern

US Nationwide distribution in the state of MA.

Field note

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