Device recall
Z-2338-2020: IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be…
FDA device recall · Class II · Philips Healthcare Informatics, Inc.
Key facts
| Recall number (Z-number) | Z-2338-2020 |
|---|---|
| Recall event | 85499 |
| Product | IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. |
| Product code | LLZ |
| Recalling firm | Philips Healthcare Informatics, Inc. |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K111804 |
| FEI number | 3002971142 |
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