Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bl
FDA device recall Z-0458-2010 · posted 2009-11-25 · Terminated
Recall details
- Recalling firm
- Nonin Medical, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MUD
- Quantity affected
- 62
- Distribution
- Worldwide Distribution -- USA, including states of LA, MN, NC, and NY and countries of Canada, Germany, Italy, Netherlands, and United Kingdom.
- Date initiated
- 2009-10-23
- Date posted
- 2009-11-25
- Date terminated
- 2012-03-29
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REGIONAL OXIMETER SYSTEM, MODEL 7600 (K090807) | Nonin Medical, Inc. | 2009-06-30 |