FDA Device recall Z-0213-2015
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of fun…
- FDA Device
- Class II
- terminated
- Published 2014-11-19
On 2014-11-19 the FDA classified a Class II recall of Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of fun… by Masimo, citing firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0213-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-30 |
| Published | 2014-11-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Masimo |
| Distribution | US |
Product
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.
Reason
Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.
Identifiers
| code_info | PART_ID LOT_ID 3311 11CE2 3311 E11EA7 3311 11EMM 3311 E11EDJ 3311 11FAU…PART_ID LOT_ID 3311 11CE2 3311 E11EA7 3311 11EMM 3311 E11EDJ 3311 11FAU 3311 11FAV 3311 11CE2 3311 11FAW 3311 11GBY 3311 11HGF 3311 11HE6 3311 11J80 3311 11JCJ 3311 11HNO 3311 11JCK 3311 11K37 3412 11MA7 3311 R11KFY 3311 11K37 3311 11KQM 3311 11NDZ 3311 12B95 3412 12CP1 3412 11AM7 3449 E12HR3 3450 E12HR4 3412 12CP1 3635 12KP4 3636 12KP5 3635 12KQ7 3636 12KQ8 3450 E12KJY 3449 E12KS3 3449 E12KT4 3450 E12KS4 3635 12MAG 3450 E12KT5 3450 E12MA2 3578 E12MA6 3577 E12ME6 3449 E12KS3 3450 E12KS4 3578 R12N2U |
|---|
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-0213-2015%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.