Device recall
Z-2596-2021: Flow sensors that may be installed in the following GEHC anesthesia machines…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-2596-2021 |
|---|---|
| Recall event | 88400 |
| Product | Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100); (5) S/5 Aespire 7900; (6) Aespire View; (7)… |
| Product code | BSZ |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K172045 |
| FEI number | 2126677 |
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