Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73825

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

Open FDA event record

Event summary

Timeline bucket
April 14, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Electronics North America Corporation

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 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

Z-1612-2016
Recall number
Z-1612-2016
Initiated
April 14, 2016
Classification
Class II
Status
Terminated
Quantity
17

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.

Code information

US00586611, US00589878, US00594232, US00588464, US00591080, US00594779, US00588657, US00592182, US00594913, US00589391, US00593861, US00595298, US00589472, US00594092, US00595443, US00589851, US00594168

Distribution pattern

Worldwide Distribution - US including OH, CA, NC and Internationally to China, Iraq, Japan, and Korea.