Recall Z-2151-2025 ยท DQA Oximeter
Covidien
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
| Date | Jul 21, 2025 (initiated Jun 23, 2025) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Labeling design |
| Action | On 6/23/2025 correction notices were distributed to customers who where informed: Per Operator s Manual (http://manuals.medtronic.com): 1) Device alarm volume needs to be set to a level appropriate to be heard throughout the care environment at all times of day or night. Do not silence or decrease the volume of the audible alarm if patient safety could be compromised. 2) If the sensor comes off the patient, or no perfusion is detected, the device will notify 'sensor off' (low priority alarm) every 16 seconds and display a steady yellow visual indicator. If a low priority alarm immediately foll |
| Quantity | 264,790 |
| Distribution | Worldwide - US Nationwide distribution including in the states of MS, TX, FL, SC, VA, AZ, PA, MN, OH, CA, MI, CO, KS, IN, IL, TN, MO, IA, OK, WI, AK, NY, MD, AL, WV, GA, NC, AR, WA, SD, KY, DE, NJ, UT, NV, MA, MT, GU, NE, LA, HI, OR, RI, NH, ND, NM, ME, CT, DC, WY and the countries of Algeria, Andor |
| FDA record | Open on fda.gov |