Device recall
Z-2027-2024: GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1…
FDA device recall · Class II · GE Medical Systems Information Technologies Inc
Key facts
| Recall number (Z-number) | Z-2027-2024 |
|---|---|
| Recall event | 94597 |
| Product | GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - 25 CM, 20/BOX; 3. ONE-A2-1B, ONE-CUF, ADULT, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 4. ONE-A1-1B-L… |
| Product code | DXQ |
| Recalling firm | GE Medical Systems Information Technologies Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K230145 |
| FEI number | 3012359877 |
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