Device recall
Z-0744-2013: KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model…
FDA device recall · Class III · Carestream Health, Inc.
Key facts
| Recall number (Z-number) | Z-0744-2013 |
|---|---|
| Recall event | 64135 |
| Product | KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography |
| Product code | IWZ |
| Recalling firm | Carestream Health, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 18, 2016 |
| FEI number | 1317267 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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