Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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, PM100N-2XMAXN-CC, PM100N-3DYS-CC, PM100N-DYS, PM100N-HC, PM100N-MAXN, PM100N-MAXN-CC, PM100N-OXIAN-CC/PT00156589 - AR - Arabic, PT00156609 - AR - Arabic, PT00156588 - BG - Bulgarian, PT00156610 - BG - Bulgarian, PT00156586 - CS - Czech, PT00156612 - CS - Czech, PT00156585 - DA - Danish, PT00156613 - DA - Danish, PT00156578 - DE - German, PT00156625 - DE - German, PT00156577 - EL - Greek, PT00156626 - EL - Greek, PT00156509 - EN - English, PT00156328 - EN - English, PT00156563 - ES - Spanish, PT00156639 - ES - Spanish, PT00156583 - ET - Estonian, PT00156615 - ET - Estonian, PT00156582 - FI - Finnish, PT00156616 - FI - Finnish, PT00156581 - FR - French, PT00156617 - FR - French, PT00156587 - HR - Croatian , PT00156611 - HR - Croatian , PT00156576 - HU - Hungarian, PT00156627 - HU - Hungarian, PT00156575 - IT - Italian, PT00156628 - IT - Italian, PT00156580 - KA - Georgian, PT00156618 - KA - Georgian, PT00156591 - KO - Korean, PT00156642 - KO - Korean, PT00156573 - LT - Lithuanian, PT00156630 - LT - Lithuanian, PT00156574 - LV - Latvian, PT00156629 - LV - Latvian, PT00156584 - NL - Dutch, PT00156614 - NL - Dutch, PT00156572 - NO - Norwegian, PT00156631 - NO - Norwegian, PT00156571 - PL - Polish, PT00156632 - PL - Polish, PT00156570 - PT-BR - Brazilian Portuguese, PT00156633 - PT-BR - Brazilian Portuguese, PT00156569 - RO - Romanian, PT00156634 - RO - Romanian, PT00156567 - RU - Russian, PT00156635 - RU - Russian, PT00156565 - SK - Slovak, PT00156637 - SK - Slovak, PT00156564 - SL - Slovenian, PT00156638 - SL - Slovenian, PT00156566 - SR - Serbian, PT00156636 - SR - Serbian, PT00156562 - SV Swedish, PT00156640 -SV - Swedish, PT00156561 - TR - Turkish, PT00156641 - TR - Turkish, PT00156590 - ZH - SimplifIed Chinese, PT00156643 - ZH - SimplifIed Chinese; 10005941/10884521163454/PM100N-10, PM100N-2XMAXN, PM100N-2XMAXN-CC, PM100N-3DYS-CC, PM100N-DYS, PM100N-HC, PM100N-MAXN, PM100N-MAXN-CC, PM100N-OXIAN-CC, BEDSIDESP2KIT2, NELLSPO2, PM100N-HC, NELL-HOMECARE, ROEBEDSIDEKIT, BEDSIDESP2PT2, BEDSIDESP2NO2, BEDSIDESP2PL2, BEDSIDESP2NL2, BEDSIDESP2KITNM, BEDSIDESP2K2UK, BEDSIDESP2K2IT, BEDSIDESP2K2FR, BEDSIDESP2K2-2, BEDSIDEKITISR/PT00156645 - AR - Arabic, PT00156647 - BG - Bulgarian, PT00156649 - CS - Czech, PT00156650 - DA - Danish, PT00156656 - DE - German, PT00156657 - EL - Greek, PT00156324 - EN - English, PT00156673 - ES - Spanish, PT00156652 - ET - Estonian, PT00156653 - FI - Finnish, PT00156654 - FR - French, PT00156648 - HR - Croatian, PT00156658 - HU - Hungarian, PT00156659 - IT - Italian, PT00156655 - KA - Georgian, PT00156677 - KO - Korean, PT00156661 - LT - Lithuanian, PT00156660 - LV - Latvian, PT00156651 - NL - Dutch, PT00156662 - NO - Norwegian, PT00156664 - PL - Polish, PT00156666 PT-BR - Brazilian Portuguese, PT00156667 - RO - Romanian, PT00156668 - RU - Russian, PT00156671 - SK - Slovak, PT00156672 - SL - Slovenian, PT00156669 - SR - Serbian, PT00156674 - SV - Swedish, PT00156675 - TR - Turkish, PT00156676 - ZH - Simplified Chinese, NELL-SPO2-AD3+ - Canadian, NELL-SPO2-AD3 - Canadian; 10005941/A8845211634501; DLPM100N/10884521527607; DL10005941/10884521173293; DSPM100N/DSPM100N; 10005941-SG/10884521171534/BNINHLLCODE, BNINNEL100A, BNINNEL100AS, BNINNEL100AVJ, BNINNEL100AYS, BNINNELDYS, BNHKLIBRANEOSET, BNHKLIBRASET; DS10005941/DS10005941; 10005941J/10005941JP; 10005941JP/884521512019; 10005941JPN/884521188689. All serial numbers
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Covidien
- Reason for Recall:
- Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
Product Codes/Lot Numbers:
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, PM100N-2XMAXN-CC, PM100N-3DYS-CC, PM100N-DYS, PM100N-HC, PM100N-MAXN, PM100N-MAXN-CC, PM100N-OXIAN-CC/PT00156589 - AR - Arabic, PT00156609 - AR - Arabic, PT00156588 - BG - Bulgarian, PT00156610 - BG - Bulgarian, PT00156586 - CS - Czech, PT00156612 - CS - Czech, PT00156585 - DA - Danish, PT00156613 - DA - Danish, PT00156578 - DE - German, PT00156625 - DE - German, PT00156577 - EL - Greek, PT00156626 - EL - Greek, PT00156509 - EN - English, PT00156328 - EN - English, PT00156563 - ES - Spanish, PT00156639 - ES - Spanish, PT00156583 - ET - Estonian, PT00156615 - ET - Estonian, PT00156582 - FI - Finnish, PT00156616 - FI - Finnish, PT00156581 - FR - French, PT00156617 - FR - French, PT00156587 - HR - Croatian , PT00156611 - HR - Croatian , PT00156576 - HU - Hungarian, PT00156627 - HU - Hungarian, PT00156575 - IT - Italian, PT00156628 - IT - Italian, PT00156580 - KA - Georgian, PT00156618 - KA - Georgian, PT00156591 - KO - Korean, PT00156642 - KO - Korean, PT00156573 - LT - Lithuanian, PT00156630 - LT - Lithuanian, PT00156574 - LV - Latvian, PT00156629 - LV - Latvian, PT00156584 - NL - Dutch, PT00156614 - NL - Dutch, PT00156572 - NO - Norwegian, PT00156631 - NO - Norwegian, PT00156571 - PL - Polish, PT00156632 - PL - Polish, PT00156570 - PT-BR - Brazilian Portuguese, PT00156633 - PT-BR - Brazilian Portuguese, PT00156569 - RO - Romanian, PT00156634 - RO - Romanian, PT00156567 - RU - Russian, PT00156635 - RU - Russian, PT00156565 - SK - Slovak, PT00156637 - SK - Slovak, PT00156564 - SL - Slovenian, PT00156638 - SL - Slovenian, PT00156566 - SR - Serbian, PT00156636 - SR - Serbian, PT00156562 - SV Swedish, PT00156640 -SV - Swedish, PT00156561 - TR - Turkish, PT00156641 - TR - Turkish, PT00156590 - ZH - SimplifIed Chinese, PT00156643 - ZH - SimplifIed Chinese; 10005941/10884521163454/PM100N-10, PM100N-2XMAXN, PM100N-2XMAXN-CC, PM100N-3DYS-CC, PM100N-DYS, PM100N-HC, PM100N-MAXN, PM100N-MAXN-CC, PM100N-OXIAN-CC, BEDSIDESP2KIT2, NELLSPO2, PM100N-HC, NELL-HOMECARE, ROEBEDSIDEKIT, BEDSIDESP2PT2, BEDSIDESP2NO2, BEDSIDESP2PL2, BEDSIDESP2NL2, BEDSIDESP2KITNM, BEDSIDESP2K2UK, BEDSIDESP2K2IT, BEDSIDESP2K2FR, BEDSIDESP2K2-2, BEDSIDEKITISR/PT00156645 - AR - Arabic, PT00156647 - BG - Bulgarian, PT00156649 - CS - Czech, PT00156650 - DA - Danish, PT00156656 - DE - German, PT00156657 - EL - Greek, PT00156324 - EN - English, PT00156673 - ES - Spanish, PT00156652 - ET - Estonian, PT00156653 - FI - Finnish, PT00156654 - FR - French, PT00156648 - HR - Croatian, PT00156658 - HU - Hungarian, PT00156659 - IT - Italian, PT00156655 - KA - Georgian, PT00156677 - KO - Korean, PT00156661 - LT - Lithuanian, PT00156660 - LV - Latvian, PT00156651 - NL - Dutch, PT00156662 - NO - Norwegian, PT00156664 - PL - Polish, PT00156666 PT-BR - Brazilian Portuguese, PT00156667 - RO - Romanian, PT00156668 - RU - Russian, PT00156671 - SK - Slovak, PT00156672 - SL - Slovenian, PT00156669 - SR - Serbian, PT00156674 - SV - Swedish, PT00156675 - TR - Turkish, PT00156676 - ZH - Simplified Chinese, NELL-SPO2-AD3+ - Canadian, NELL-SPO2-AD3 - Canadian; 10005941/A8845211634501; DLPM100N/10884521527607; DL10005941/10884521173293; DSPM100N/DSPM100N; 10005941-SG/10884521171534/BNINHLLCODE, BNINNEL100A, BNINNEL100AS, BNINNEL100AVJ, BNINNEL100AYS, BNINNELDYS, BNHKLIBRANEOSET, BNHKLIBRASET; DS10005941/DS10005941; 10005941J/10005941JP; 10005941JP/884521512019; 10005941JPN/884521188689. All serial numbers
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2151-2025
Related Recalls
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.