Recall Z-0602-2014 ยท GWM Device, Monitoring, Intracranial Pressure
Integra LifeSciences Corp.
Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or Temperature are measured at the Catheter tip, eliminating the need for external transducers,
| Date | Dec 27, 2013 (initiated Nov 26, 2013) |
| Status | Terminated |
| Reason | Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4 Firmware, the displayed values for the systolic and diastolic intracranial pressure (ICP) are reversed. But, if the CAM01 is used with an auxiliary bedside monitor, the bedside monitor displays these values correctly. |
| Root cause | Device Design |
| Action | Integra sent an Urgent Medical Device Correction letter and Correction Acknowledgement form dated November 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you received one or more of the affected serial numbers that will require this firmware update. Integra asks that you do the following: 1. Review your inventory and verify that you have Camino Advanced Monitors with a serial number formatted as MExxxxxx04. If so, you can continue to use the CAM01 monitor(s), being aware that if y |
| Quantity | 275 CAM01 Monitors |
| Distribution | Worldwide Distribution - USA ( Nationwide ) and the countries of : UK, Saudi Arabia, South Africa, Brunei, China, France, Poland, Turkey, Greece, Sweden, United Arab Emirates, Russia, Spain, Pakistan, Finland, Israel, Italy, Slovenia, Japan, Poland, Malaysia, Germany and Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962928 | COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) Camino Neurocare, Inc., Dec 20, 1996 |