Device recall
Z-0854-2019: PageWriter TC50, Product 860310, Software revisions up to and including…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-0854-2019 |
|---|---|
| Recall event | 81957 |
| 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 |
| Product code | DPS |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K113144 |
| FEI number | 1218950 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database