Device recall
Z-2135-2020: Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail…
FDA device recall · Class II · MOTEK MEDICAL B.V.
Key facts
| Recall number (Z-number) | Z-2135-2020 |
|---|---|
| Recall event | 85301 |
| Product | Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be… |
| Product code | BXB |
| Recalling firm | MOTEK MEDICAL B.V. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3006750942 |
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