Device recall
Z-1593-2016: CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490…
FDA device recall · Class II · Carestream Health Inc
Key facts
| Recall number (Z-number) | Z-1593-2016 |
|---|---|
| Recall event | 73742 |
| Product | CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona… |
| Product code | LLZ |
| Recalling firm | Carestream Health Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 16, 2017 |
| 510(k) numbers | K100094 |
| FEI number | 1315356 |
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