Device recall
Z-2046-2018: Draeger Jaundice Meter JM-103 The device is intended for use in hospitals…
FDA device recall · Class I · Draeger Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2046-2018 |
|---|---|
| Recall event | 79963 |
| Product | Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used… |
| Product code | MQM |
| Recalling firm | Draeger Medical Systems, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 8, 2023 |
| 510(k) numbers | K042522 |
| FEI number | 2510954 |
At a glance
- 1–9 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