Device recall
Z-2611-2011: Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure…
FDA device recall · Class II · Spacelabs Healthcare, Llc
Key facts
| Recall number (Z-number) | Z-2611-2011 |
|---|---|
| Recall event | 59004 |
| Product | Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is labeled in part: "***Pathfinder Holter Analyzer ***Spacelabs Healthcare Company Headquarters***5150 220th Ave. SE, Issaquah, WA 98029***PO Box 7018, Issaquah, WA 98027-7018***Telephone: 425-657-7200***In North America… |
| Product code | DQK |
| Recalling firm | Spacelabs Healthcare, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 26, 2011 |
| 510(k) numbers | K951902 |
| FEI number | 3010157426 |
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