Recall Z-1690-2017 ยท DQA Oximeter
Nonin Medical, Inc
8500M Handheld Pulse Oximeter
| Date | Sep 29, 2016 |
| Status | Terminated |
| Reason | Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature. |
| Root cause | Process control |
| Action | Consignees were called and sent on 9-29-2016 a Nonin Urgent Medical Device Recal" letter dated 29 September, 2016. The letter described the problem and the product involved in the recall. Additionally, it described the Potential Risk and Required Action. Requested consignees to return the affected units and to forward the contact information if the unit is no longer in their inventory. For questions contact Kim.Aves@nonin.com or via direct telephone at 763 577 3196. |
| Quantity | 15 (11 US; 4 OUS) |
| Distribution | Distribution in US (MI, NC, OH, NC, VA), and CANADA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K893221 | MODEL 8500 HAND HELD PULSE OXIMETER Nonin Medical, Inc., Feb 28, 1990 |