FDA Device recall Z-2268-2015
OxiMax N-560 Pulse Oximeter
- FDA Device
- Class II
- terminated
- Published 2015-08-05
On 2015-08-05 the FDA classified a Class II recall of OxiMax N-560 Pulse Oximeter by Covidien Formerly Nellcor Puritan Bennett, citing potential missing segments on the display that can result in misinterpretation of data.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2268-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-29 |
| Published | 2015-08-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Covidien Formerly Nellcor Puritan Bennett |
| Distribution | US |
Product
OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
Reason
Potential missing segments on the display that can result in misinterpretation of data.
Identifiers
| code_info | All Lots, Product code N560 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2268-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.