Recall Z-0458-2010 ยท MUD Oximeter, Tissue Saturation
Nonin Medical, Inc
Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Nonin Medical, Inc., 13700 First Avenue North, Plymouth, Minnesota 55441-5443 USA.
| Date | Nov 25, 2009 (initiated Oct 23, 2009) |
| Status | Terminated |
| Reason | A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact with the patient. |
| Root cause | Device Design |
| Action | An Urgent: Medical Device Recall letter was emailed to customers on 10/23/2009. The letter described the issue and hazard and asked that the use of the device be discontinued and to immediately contact Nonin for return and repair/replacement instructions. Questions or concerns should be directed to John Dalpee at 763-577-3166. |
| Quantity | 62 |
| Distribution | Worldwide Distribution -- USA, including states of LA, MN, NC, and NY and countries of Canada, Germany, Italy, Netherlands, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090807 | REGIONAL OXIMETER SYSTEM, MODEL 7600 Nonin Medical, Inc., Jun 30, 2009 |