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Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in...

FDA Device Recall #Z-2137-2020 — Class II — April 21, 2020

Recall Summary

Recall Number Z-2137-2020
Classification Class II — Moderate risk
Date Initiated April 21, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips North America, LLC
Location Andover, MA
Product Type Devices
Quantity 130 units (US 126; OUS 4)

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Lot / 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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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