Recall Z-0861-2019 ยท DPS Electrocardiograph
Philips North America, LLC
PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
| Date | Jan 9, 2019 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Use error |
| Action | 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 |
| Quantity | 14 |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113144 | PAGEWRITER TC 20, 30, 50, 70 Philips Medical Systems, Apr 3, 2012 |