| Date Initiated by Firm |
April 21, 2020 |
| Create Date |
May 28, 2020 |
| Recall Status1 |
Terminated 3 on July 16, 2021 |
| Recall Number |
Z-2137-2020 |
| Recall Event ID |
85580 |
| Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
|
| 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 |
| 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 |
Recalling Firm/
Manufacturer |
Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
|
| For Additional Information Contact |
Philips Customer Services
800-722-9377
|
Manufacturer Reason
for Recall |
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
|
FDA Determined
Cause 2 |
Process control |
| Action |
Philips issued Urgent Medical Device Removal (FSNB6100215A) on 4/21/20 to U.S. customers via certified mail. Philips Markets Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take:
Upon receipt of this notification, promptly locate the affected XL M4735A device
listed on page 3, Appendix A, of this notification and remove them from clinical
use immediately.
A Philips representative will contact you to confirm that each device has been
PHILIPS removed from service. Philips intends to take no further action beyond this notification as the XL is beyond its support life and is no longer serviceable.
If you need further information or support concerning this notification, please
contact your local Philips representative or call us at 1-800-722-9377. |
| Quantity in Commerce |
130 units (US 126; OUS 4) |
| Distribution |
Worldwide distribution - US Nationwide distribution including in the states of KY, MA, ND, NY and the countries of United Kingdom, Bahrain. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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