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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75041

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

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Event summary

Timeline bucket
August 26, 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 Models: M3535A and M3536A

Z-2842-2016
Recall number
Z-2842-2016
Initiated
August 26, 2016
Classification
Class II
Status
Terminated
Quantity
394 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The handle can separate from the MRx housing due to breakage of mounts on the rear case.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The handle can separate from the MRx housing due to breakage of mounts on the rear case.

Code information

US Serial Numbers: US00100227 US00100297 US00100326 US00100337 US00100429 US00100715 US00101184 US00101468 US00101676 US00101690 US00102018 US00203809 US00205745 US00205756 US00206142 US00206498 US00206615 US00206821 US00207095 US00207101 US00207144 US00207209 US00207268 US00207295 US00207321 US00207324 US00207345 US00208019 US00208263 US00208431 US00208519 US00210744 US00210966 US00211478 US00211485 US00212939 US00213455 US00213819 US00214103 US00214173 US00214222 US00316387 US00316389 US00316444 US00317530 US00318184 US00318460 US00321017 US00321936 US00323885 US00325280 US00326630 US00327632 US00328050 US00328154 US00328968 US00330028 US00330043 US00330093 US00331414 US00332111 US00534036 US00534522 US00535148 US00535803 US00539517 US00540460 US00541251 US00541256 US00541257 US00541366 US00541627 US00543683 US00543856 US00544956 US00545221 US00545649 US00554157 US00555242 US00571887 US00574441 US00574758 Canada: US00100770 US00101622 US00101811 US00204864 US00204987 US00205107 US00325446 US00325734 US00539650 US00565585 US00569569 ROW: US00101691 US00208635 US00327490 US00101209 US00206875 US00208214 US00209571 US00212610 US00212964 US00100372 US00536445 US00100883 US00207958 US00100861 US00211015 US00100171 US00100628 US00534545 US00321215 US00205732 US00208194 MRx units that have the Old Cap Plate, shipped before 2010.

Distribution pattern

Worldwide distribution. US Nationwide, Canada, AUSTRALIA, FRANCE, GERMANY, INDIA, JAPAN, NETHERLANDS, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, and UNITED KINGDOM.