FDA Device recall Z-1536-2024
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only by Masimo, citing their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1536-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-15 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Masimo |
| Distribution | US |
Product
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Reason
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Identifiers
| code_info | UDI: (01)00843997008013/Serial Numbers: 6000083855 6000083985 6000083987 6000083992 6000083996 6000084000 6000084003 60…UDI: (01)00843997008013/Serial Numbers: 6000083855 6000083985 6000083987 6000083992 6000083996 6000084000 6000084003 6000084005 6000084009 6000084010 6000084012 6000084013 6000084015 6000084016 6000084038 6000084046 6000084052 6000084057 6000084059 6000084060 6000084064 6000084067 6000084071 6000084080 6000084134 6000084140 6000084165 6000084175 6000084184 6000084192 6000084196 6000084197 6000084200 6000084201 6000084202 6000084207 6000084266 6000084278 6000084279 6000084280 6000084282 6000084284 6000084285 6000084286 6000084287 6000084288 6000084289 6000084296 6000084299 6000084306 6000084310 6000084313 6000084314 6000084315 6000084317 6000084318 6000084319 6000084321 6000084325 6000084326 6000084328 6000084329 6000084331 6000084332 6000084398 6000084410 6000084418 6000084424 6000084478 6000084481 6000084512 6000084546 6000084553 6000084554 6000084556 6000084562 6000084565 6000084566 6000084580 6000084583 6000084590 6000084591 6000084592 6000084593 6000084594 6000084596 6000084598 600 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1536-2024%22
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