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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85580

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

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Event summary

Timeline bucket
April 21, 2020
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

Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation

Z-2137-2020
Recall number
Z-2137-2020
Initiated
April 21, 2020
Classification
Class II
Status
Terminated
Quantity
130 units (US 126; OUS 4)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections

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

HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections

Code information

Serial Numbers: US00127349 US00127341 US00127347 US00127355 US00127357 US00127346 US00126134 US00126145 US00126129 US00126130 US00126131 US00126132 US00126133 US00126135 US00126136 US00126137 US00126141 US00126142 US00126144 US00126146 US00126147 US00126148 US00126168 US00126169 US00126171 US00126172 US00126173 US00126174 US00126175 US00126176 US00126177 US00126179 US00126180 US00126181 US00126182 US00126183 US00126184 US00126185 US00126186 US00126187 US00127365 US00127345 US00127353 US00127362 US00127364 US00124799 US00124800 US00126138 US00126139 US00126140 US00126143 US00126380 US00126381 US00126382 US00126383 US00127371 US00127372 US00127318 US00127334 US00127335 US00127336 US00127337 US00127338 US00127339 US00127340 US00127342 US00127343 US00127344 US00127348 US00127350 US00127351 US00127354 US00127356 US00127358 US00127359 US00127360 US00127361 US00127363 US00127366 US00127367 US00127368 US00127369 US00127370 US00128359 US00128411 US00230152 US00230153 US00230154 US00230155 US00230156 US00230157 US00128692 US00230709 US00232426 US00574878 US00575747 US00575748 US00575749 US00575750 US00575751 US00582246 US00582247 US00582248 US00582249 US00582250 US00589872 US00593616 US00593617 US00593618 US00593619 US00595090 US00595421 US00595424 US00595425 US00602424 US00602425 US00602426 US00602427 US00602428 US00602429 US00602430 US00126170 US00126178 US00122814 US00127352 US00123379 US00446868 US00579838 US00579839 US00579840

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of KY, MA, ND, NY and the countries of United Kingdom, Bahrain.

Field note

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