Device recall
Z-0029-2020: Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807…
FDA device recall · Class III · CooperSurgical, Inc.
Key facts
| Recall number (Z-number) | Z-0029-2020 |
|---|---|
| Recall event | 83108 |
| Product | Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are… |
| Product code | MQG |
| Recalling firm | CooperSurgical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 2, 2021 |
| 510(k) numbers | K160504 |
| FEI number | 1216677 |
At a glance
- 1–9 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