Device recall
Z-2822-2026: Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3…
FDA device recall · Class II · Instrumentation Laboratory
Key facts
| Recall number (Z-number) | Z-2822-2026 |
|---|---|
| Recall event | 99115 |
| Product | Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. |
| Product code | CHL |
| Recalling firm | Instrumentation Laboratory |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K223608 |
| FEI number | 1217183 |
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