Device recall
Z-2267-2014: IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a…
FDA device recall · Class II · Intelerad Medical Systems
Key facts
| Recall number (Z-number) | Z-2267-2014 |
|---|---|
| Recall event | 68719 |
| Product | IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging… |
| Product code | LLZ |
| Recalling firm | Intelerad Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 13, 2016 |
| 510(k) numbers | K083520 |
| FEI number | 3008437943 |
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