| Class 2 Device Recall Philips | |
Date Initiated by Firm | January 25, 2019 |
Create Date | March 28, 2019 |
Recall Status1 |
Terminated 3 on April 21, 2020 |
Recall Number | Z-1067-2019 |
Recall Event ID |
82264 |
Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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Product | Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX40 is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center, the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center. The MX40 can provide time-limited local monitoring when it is not connected to the wireless network. |
Code Information |
Lot 2018-28 |
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 | Lithium-ion Rechargeable Batteries for the Philips MX4O
Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor |
FDA Determined Cause 2 | Process control |
Action | Philips issued an email on January 25, 2019 informing customers the batteries on hold had been inadvertently shipped. Philips is asking customers to follow the Action to be Taken by Customer/User should check all MX40s that may contain an affected battery, immediately remove any affected batteries found and replace them with unaffected batteries. The batteries should be returned with the RMA number and return label provided by Philips following any special requirements for shipping lithium-ion batteries specified by the carrier they select |
Quantity in Commerce | 40 |
Distribution | US Nationwide distribution in the states of AK, CA, CO, IN,MI, NC, ND, NM, OR, TN, TX and UT. |
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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