Recall Z-2267-2015 ยท DQA Oximeter
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
| Date | Jul 27, 2015 (initiated Jun 29, 2015) |
| Status | Terminated |
| Reason | Potential missing segments on the display that can result in misinterpretation of data. |
| Root cause | Device Design |
| Action | Metronic sent an Urgent Medical Device Correction letter dated June 29, 2015 to affected customers. The letter identified the adfected product, problem and actions to be taked. Customers where instructed to return the attached verification form. For questions contact your Medtronic representative. |
| Quantity | 211,426 units |
| Distribution | Worldwide Distribution - US Nationwide including Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123581 | NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN Covidien, Formerly Nellcor Puritan Bennett, Inc., May 9, 2013 |