Device recall
Z-1819-2012: US-001 Rev A brochure is a two sided tri-fold printed marketing brochure…
FDA device recall · Class II · Non-Invasive Monitoring Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1819-2012 |
|---|---|
| Recall event | 61868 |
| Product | US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration… |
| Product code | IRO |
| Recalling firm | Non-Invasive Monitoring Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 16, 2012 |
| FEI number | 2431353 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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