Date Initiated by Firm | April 13, 2020 |
Create Date | May 20, 2020 |
Recall Status1 |
Terminated 3 on April 07, 2021 |
Recall Number | Z-2053-2020 |
Recall Event ID |
85147 |
510(K)Number | K001725 |
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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Product | Philips HeartStart XL Defibrillator/Monitor (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. It must be used by or on the order of a physician. |
Code Information |
All units. Product has been discontinued. |
Recalling Firm/ Manufacturer |
Philips North America, LLC 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact | Philips Customer Services 800-722-9377 |
Manufacturer Reason for Recall | The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.
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FDA Determined Cause 2 | Process control |
Action | On April 13, 2020, the firm distributed URGENT Medical Device Recall letters to affected customers. Customers were informed of the device defect, which may result in the following unexpected behavior:
- The device may not turn on.
- The device may not perform the selected function.
- The device may deliver a shock with an energy level different from the setting selected by the user.
There have been three reported patient deaths potentially associated with the failure of the HeartStart XL Monitor/Defibrillator rotary therapy selector switch.
Customers were advised that the HeartStart XL Defibrillator/Monitor has been discontinued and has reached its end of life. Therefore, custoemrs should replace and retire their units as soon as practically possible.
Customers should continue to perform Shift Checks and Operational checks as recommended in the Instructions for Use (IFU) as this reduces the risk of a failure until your units are safely retired.
If you identify a device that exhibits any of the behaviors described above, or which fails shift or operational checks, immediately remove it from service.
Customers were asked to complete and fax or email the included customer reply form to Philips.
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 | 94,034 units |
Distribution | Worldwide distribution - US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = MKJ
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