FDA Device recall Z-2137-2020
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personne…
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personne… by Philips North America, citing heartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2137-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-21 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
Product
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
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
Identifiers
| code_info | Serial Numbers: US00127349 US00127341 US00127347 US00127355 US00127357 US00127346 US00126134 US00126145 US0012…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2137-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.