FDA Device recall Z-0602-2014
Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Cam…
- FDA Device
- Class II
- terminated
- Published 2014-01-08
On 2014-01-08 the FDA classified a Class II recall of Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Cam… by Integra Lifesciences, citing 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 valu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0602-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-26 |
| Published | 2014-01-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
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, fluid, pressure tubing, and flush devices. The Camino displays intracranial pressure (ICP), intracranial temperature (ICT), and calculates cerebral perfusion pressure (CPP) (CPP = mean arterial pressure - mean intracranial pressure). The Camino provides a continuous display of the ICP waveform, as well as mean ICP, CPP, ICT, or systolic and diastolic waveform values. A continuous record of mean pressure and CPP values over the most recent 24-hour period is stored in memory, and can be displayed on command as a TREND either as the most recent 12 or 24 hour period. Outputs for ICP and ICT are available for use with patient bedside monitors. An isolated analogue output provides a continuous ICP waveform for hard copy documentation or data acquisition. An input to receive mean arterial pressure from a compatible patient bedside monitor is available for use when it is desired to have a CPP reading. The mean arterial pressure cannot be acquired from a non-invasive blood pressure cuff. Although the Camino is intended to be a stand-alone system, it also conveniently connects to hospital bedside monitoring systems.
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.
Identifiers
| code_info | MEK1200104 MEK1200204 MEK1200304 MEK1200404 MEK1200504 MEK1200604 MEK1200704 MEK1200804 MEK1200904 MEK1201004…MEK1200104 MEK1200204 MEK1200304 MEK1200404 MEK1200504 MEK1200604 MEK1200704 MEK1200804 MEK1200904 MEK1201004 MEK1201104 MEK1201204 MEK1201304 MEK1201404 MEK1201504 MEK1201604 MEK1201704 MEK1201804 MEK1201904 MEK1202004 MEL1200104 MEL1200204 MEL1200304 MEL1200404 MEL1200504 MEL1200604 MEL1200704 MEL1200804 MEL1200904 MEL1201004 MEL1201104 MEL1201204 MEL1201304 MEL1201404 MEL1201504 MEL1201604 MEL1201704 MEL1201804 MEL1201904 MEL1202004 MEL1202104 MEL1202204 MEL1202304 MEL1202404 MEL1202504 MEL1202604 MEL1202704 MEL1202804 MEL1202904 MEL1203004 MEL1203104 MEL1203204 MEL1203304 MEL1203404 MEL1203504 MEL1203604 MEL1203704 MEL1203804 MEL1203904 MEL1204004 MEL1204104 MEL1204204 MEL1204304 MEL1204404 MEL1204504 MEL1204604 MEL1204704 MEL1204804 MEL1204904 MEL1205004 MEM1200104 MEM1200204 MEM1200304 MEM1200404 MEM1200504 MEM1200604 MEM1200704 MEM1200804 MEM1200904 MEM1201004 MEM1201104 MEM1201204 MEM1201304 MEM1 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0602-2014%22
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