Recall Z-0856-2019
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 TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Codes / lots: CN11201318 CN11201319 CN11201320 CN11201321 CN11201322 CN11201323 CN11201324 CN11201325 CN11201326 CN11201327 CN11201328 CN11201329 CN11201330 CN11201331 CN11201332 CN11201333 CN11201334 CN11201335 CN11201336 CN11201337 CN11201338 CN11201339 CN11201340 CN11201341 CN11201342 CN11201343 CN11201344 CN11201345 CN11201346 CN11201347 CN11201348 CN11201349 CN11201350 CN11201351 CN11201352 CN11201353 CN11201354 CN11201355 CN11201356 CN11201357 CN11201358 CN11201359 CN11201360 CN11201361 CN11201362 CN11201363 CN11201364 CN11201365 CN11201366 CN11201371 CN11201372 CN11201373 CN11201374 CN11201375 CN11201376 CN11201377 CN11201378 CN11201379 CN11201380 CN11201381 CN11201382 CN11201383 CN11201384 CN11201385 CN11201386 CN11201387 CN11201388 CN11201389 CN11201390 CN11201391 CN11201392 CN11201393 CN11201394 CN11302185 CN11302186 CN11302187 CN11302188 CN11302190 CN11302191 CN11302192 CN11302193 CN11302194 CN11302195 CN11302196 CN11302197 CN11302198 CN11302199 CN11302200 CN11302201 CN11302202 CN11302203 CN11302204 CN11302205 CN11302206 CN11302207 CN11302208 CN11302209 CN11302210 CN11302211 CN11302212 CN11302213 CN11302214 CN11302215 CN11302216 CN11302217 CN11302218 CN11302219 CN11302220 CN11302221…
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-0856-2019
- Initiated
- January 9, 2019
- Product code
- DPS – Electrocardiograph
- Quantity
- 14067
- 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-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-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 |