Recall Z-0854-2019
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 TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Codes / lots: CN11102314 CN11102315 CN11102316 CN11102317 CN11203436 CN11203443 CN11203444 CN11203453 CN11203454 CN11203455 CN11304748 CN11304749 CN11304762 CN11304772 CN11304773 CN11304802 CN11304803 CN11304805 CN11304806 CN11304809 CN11406020 CN11406033 CN11406034 CN11507236 CN11507237 CN11507238 CN11507259 CN11507260 CN11507261 CN11507262 CN11507263 CN11507264 CN11630099 CN11630100 CN11630101 CN11630102 CN11630103 CN11630104 CN11630105 CN11630106 CN11630107 CN11630108 CN11630109 CN11630110 CN11630111 CN11630112 CN11630113 CN11630114 CN11630122 CN11630123 CN11630124 CN11630125 CN11630126 CN11630128 CN11630129 CN11630130 CN11630131 CN11630132 CN11630133 CN11630134 CN11630135 CN11630136 CN11630138 CN11630139 CN11630140 CN11630141 CN11630142 CN11630143 CN11630144 CN11630145 CN11630146 CN11630147 CN11630148 CN11630149 CN11630150 CN11630151 CN11630154 CN11630155 CN11630156 CN11630157 CN11630158 CN11630159 CN11630160 CN11630164 CN11630165 CN11630166 CN11630173 CN11630174 CN11630175 CN11630176 CN11630177 CN11630178 CN11630179 CN11630180 CN11630181 CN11630182 CN11630183 CN11630184 CN11630185 CN11630186 CN11630187 CN11630188 CN11630189 CN11630190 CN11630191 CN11630192 CN11630193 CN11630194 CN11630195…
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-0854-2019
- Initiated
- January 9, 2019
- Product code
- DPS – Electrocardiograph
- Quantity
- 11332
- 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-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 |