PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients

Recall Insight

This FDA Devices action (record #Z-0854-2019) was formally reported on February 27, 2019, with the manufacturer initiating the action on January 9, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Philips North America, LLC is listed as the recalling firm, operating out of Andover, MA. Federal records indicate 11332 units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Domestic distribution nationwide. Foreign distribution worldwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.