Recall Z-0853-2019
Philips North America, LLC · initiated January 9, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Codes / lots: CN80811000 CN80811001 F5N7000106 F5N7000107 F5O7000002 F5O7000024 F5O7000027 F5O7000037 F5O7000078 F5O7000085 F5O7000091 F5O7000093 US10901771 US10901772 US10901773 US10901774 US10901775 US10901776 US10901777 US10901778 US10901779 US10901782 US10901783 US10901784 US10901785 US10901786 US10901787 US10901788 US10901789 US10901790 US10901791 US10901792 US10901793 US10901794 US10901795 US10901796 US10901797 US10901798 US10901799 US10901800 US10901801 US10901802 US10901803 US10901804 US10901805 US10901806 US10901807 US10901808 US10901809 US10901810 US10901811 US10901812 US10901813 US10901814 US10901815 US10901816 US10901817 US10901818 US10901819 US10901821 US10901822 US10901823 US10901824 US10901825 US10901826 US10901829 US10901830 US10901831 US10901832 US10901833 US10901834 US10901835 US10901836 US10901837 US10901838 US10901839 US10901840 US10901841 US10901842 US10901843 US10901844 US10901845 US10901846 US10901847 US10901848 US10901850 US10901851 US10901852 US10901853 US10901854 US10901855 US10901856 US10901857 US10901858 US10901859 US10901860 US10901861 US10901862 US10901863 US10901864 US10901865 US10901866 US10901867 US10901868 US10901869 US10901870 US10901871 US10901872 US10901873…
Reason for recall
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
FDA-determined cause: Use error
Action taken
On December 8, 2018, Philips issued an Urgent Medical Device Correction letter to its customers, informing them of the product issue. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction/Field Safety Notice This includes requesting that users: Carefully read the PageWriter TC Service Manual Addendum and to review this information with all staff members who are responsible for device management of the Philips PageWriter TC cardiographs Promptly determine the number of cycles and the State of Health (SOH) on each of the affected Philips PageWriter TC cardiographs (TC20/30/50/70), as specified in the Service Manual Addendum. Replace the battery if the number of cycles is greater than 300 and/or if the SOH is less than 80. Customers are instructed to complete and return the response card provided with the notice. Philips is instructing customers that once it is determined the battery is not in need of replacement, or once the battery is replaced, the PageWriter PC Cardiograph is safe to continuing using. Philips plans to release a customer installable, software update for PageWriter TC cardiograph (TC20/30/50/70) that will provide alerts to assist users in managing the battery replacement cycle. Users will be notified when the customer installable software update is available. The software will provide notification the customer when it is time to replace the battery, based on charge-discharge cycle count and the batteries state of health (SOH).
Details
- Recall number
- Z-0853-2019
- Initiated
- January 9, 2019
- Product code
- DPS – Electrocardiograph
- Quantity
- 15,064
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Recalling firm
- Philips North America, LLC, Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0854-2019 Class II | PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | 01/09/2019Open, Classified |
| Z-0855-2019 Class II | PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | 01/09/2019Open, Classified |
| Z-0856-2019 Class II | PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | 01/09/2019Open, Classified |
| Z-0857-2019 Class II | PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | 01/09/2019Open, Classified |
| Z-0858-2019 Class II | PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | 01/09/2019Open, Classified |
| Z-0859-2019 Class II | PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | 01/09/2019Open, Classified |
| Z-0860-2019 Class II | PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | 01/09/2019Open, Classified |
| Z-0861-2019 Class II | PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | 01/09/2019Open, Classified |