Recall Z-0855-2019
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 TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Codes / lots: CN11102185 CN11102186 CN11102187 CN11102188 CN11102189 CN11102190 CN11102223 CN11102224 CN11102287 CN11204687 CN11204688 CN11204689 CN11204690 CN11204691 CN11204692 CN11204698 CN11204699 CN11204700 CN11204701 CN11204702 CN11204703 CN11204704 CN11204705 CN11204706 CN11204707 CN11204708 CN11204709 CN11204710 CN11204711 CN11204712 CN11204713 CN11204714 CN11204715 CN11204758 CN11204759 CN11204760 CN11204761 CN11204762 CN11204763 CN11204764 CN11204765 CN11204766 CN11204767 CN11204768 CN11204769 CN11204770 CN11204771 CN11204772 CN11204773 CN11204774 CN11204775 CN11204776 CN11204777 CN11204778 CN11204779 CN11204780 CN11204820 CN11306743 CN11306744 CN11306745 CN11306746 CN11306763 CN11306764 CN11306765 CN11306766 CN11306767 CN11306768 CN11306829 CN11306830 CN11306831 CN11306832 CN11306833 CN11306834 CN11510041 CN11510042 CN11510043 CN11510044 CN11510045 CN11510046 CN11510047 CN11510048 CN11510049 CN11510050 CN11510051 CN11510052 CN11510053 CN11510074 CN11510075 CN11510076 CN11510077 CN11510078 CN11510079 CN11510080 CN11510081 CN11510082 CN11510083 CN11510084 CN11510085 CN11510086 CN11510087 CN11510088 CN11510089 CN11510090 CN11510091 CN11510092 CN11510093 CN11510094 CN11510095 CN11510096…
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-0855-2019
- Initiated
- January 9, 2019
- Product code
- DPS – Electrocardiograph
- Quantity
- 13239
- 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-0853-2019 Class II | PageWriter TC70, Product 860315, 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-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-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 |