Nellcor bedside SpO2 monitor alarms may not be heard or recognized
The Covidien Nellcor Bedside SpO2 Patient Monitoring System is being recalled because alarms may not be heard or recognized, which the manufacturer links to treatment delay. 264,790 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: alarms on an oxygen saturation monitor that may not be heard, with no injury reported in the source.
Plain-English summary
The Covidien Nellcor Bedside SpO2 Patient Monitoring System is being recalled across REF numbers PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP and 10005941JPN. The action covers 264,790 units.
The stated reason is that Bedside SpO2 Patient Monitoring System alarms may not be heard or recognized, resulting in treatment delay, lack of low oxygen saturation response, respiratory failure and arrhythmia. The manufacturer is highlighting three points in the operator's manual: for patient safety, do not silence or decrease the alarm volume; the sensor off alarm, meaning no perfusion detected, is a low priority alarm; and monitors should be set to Homecare Mode outside a hospital or professional setting. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide across a large number of US states.
Facilities and home users should identify affected monitors using the REF and UDI codes in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
- Manufacturer
- Covidien
- Category
- Medical Device — Patient monitor
- Affected units
- 264,790
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UI-DI/Bundle Code/IFU Part Number: PM100N/10884521196728/NELL-HOMECARE
- BNPULSOKSYMETR
- PM100N
- PM100NKIT
- PM100NKITCHDE
- PM100NKITCHFR
- PM100NKITDA
- PM100NKITDE-2
- PM100NKITES
- PM100NKITFI
- PM100NKITFR
- PM100NKIT-FR
- PM100NKITIT
- PM100NKIT-NL
- PM100NKITNO
- PM100NKITPT
- PM100NKITSV
- PM100NKITUK
- PM100N-10
- PM100N-2XMAXN
Distribution
Related recalls
Same manufacturer · Covidien
See all →- SevereCovidien Newport HT70 and HT70Plus Ventilators Capacitor Failure Recall
FDA (Devices) · 2025-06-18
- SevereShiley Adult Tracheostomy Tubes Recalled Due to Flange Disconnection Risk
FDA (Devices) · 2025-04-02
- CriticalMcGrath Mac Video Laryngoscope battery depletion may cause thermal event and explosion
FDA (Devices) · 2024-08-28
- ModerateCovidien McGRATH MAC Video Laryngoscope Instruction Update for Battery Handling
FDA (Devices) · 2024-08-28
- SevereMcGRATH MAC EMS Video Laryngoscope Battery Management System Recall
FDA (Devices) · 2024-08-28
Similar recalls
- HighCovidien Nellcor SpO2 Forehead Sensor Recalled for Latex Labeling Error
FDA (Devices) · 2017-02-08
- HighGE Healthcare Recalls Nellcor SpO2 Upgrade Kits Due to Software Defect
FDA (Devices) · 2014-05-14
- HighGE Healthcare Recalls Panda Wall-Mount Infant Warmers Due to Software Defect
FDA (Devices) · 2014-05-14
- HighGE Healthcare Recalls Panda iRes Infant Warmers Due to Alarm Defect
FDA (Devices) · 2014-05-14
- HighPatient monitors recalled over potential activation of an abnormal alarm pause
FDA (Devices) · 2025-10-01
- HighPhilips IntelliVue MP2 Patient Monitors Recalled for Speaker Failure
FDA (Devices) · 2020-12-16