OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and
FDA device recall Z-2268-2015 · posted 2015-07-27 · Terminated
Recall details
- Recalling firm
- Covidien LP (formerly Nellcor Puritan Bennett Inc.)
- Reason for recall
- Potential missing segments on the display that can result in misinterpretation of data.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 105,831 units
- Distribution
- Worldwide Distribution - US Nationwide including Canada.
- Date initiated
- 2015-06-29
- Date posted
- 2015-07-27
- Date terminated
- 2017-11-03
- Location
- Boulder, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN (K123581) | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2013-05-09 |