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U.S. Department of Health and Human Services

Class 2 Device Recall Integra

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  Class 2 Device Recall Integra see related information
Date Initiated by Firm November 26, 2013
Date Posting Updated December 27, 2013
Recall Status1 Terminated 3 on February 13, 2015
Recall Number Z-0602-2014
Recall Event ID 67094
510(K)Number K962928  
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
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.

Code Information 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, MEM1201404, MEM1201504, MEM1201604, MEM1201704, MEM1201804, MEM1201904, MEM1202004, MEM1202104, MEM1202204, MEM1202304, MEM1202404

MEM1202504, MEM1202604, MEM1202704, MEM1202804, MEM1202904, MEM1203004, MEM1203104, MEM1203204, MEM1203304, MEM1203404, MEM1203504, MEM1203604, MEM1203704, MEM1203804, MEM1203904, MEM1204004, MEA1300104, MEA1300204, MEA1300304, MEA1300404, MEA1300504, MEA1300604, MEA1300704, MEA1300804, MEA1300904, MEA1301004, MEA1301104, MEA1301204, MEA1301304, MEA1301404, MEA1301504, MEA1301604, MEA1301704, MEA1301804, MEC1300104, MEC1300204, MEC1300304, MEC1300404, MEC1300504, MEC1300604, MEC1300704, MEC1300804, MEC1300904, MEC1301004, MEC1301104, MEC1301204, MEC1301404, MEC1301504, MEC1301604, MEC1301704, MEC1301804, MEC1301904, MEC1302004, MED1300104, MED1300204, MED1300304, MED1300404, MED1300504, MED1300604, MED1300704, MED1300804, MED1300904, MED1301004, MED1301104, MED1301204, MED1301304, MED1301404, MED1301504, MED1301604, MED1301704, MED1301804, MED1301904, MED1302004, MEE1300104, MEE1300204, MEE1300304, MEE1300404, MEE1300504, MEE1300604, MEE1300704, MEE1300804, MEE1300904, MEE1301004, MEE1301104, MEE1301204, MEE1301304, MEE1301404, MEE1301504, MEE1301604, MEE1301704, MEE1301804, MEE1301904, MEE1302004, MEE1302104

MEE1302204, MEE1302304, MEE1302404, MEE1302504, MEE1302604, MEE1302704, MEE1302804, MEE1302904, MEE1303004, MEE1303104, MEE1303204, MEF1300104, MEF1300204, MEF1300304, MEF1300404, MEF1300504, MEF1300604, MEF1300704, MEF1300804, MEF1300904, MEF1301104, MEF1301204, MEF1301304, MEF1301404, MEF1301504, MEF1301604, MEF1301704, MEF1301804, MEF1301904, MEF1302004, MEF1302104, MEF1302204, MEF1302304, MEF1302404, MEF1302504, MEF1302604, MEF1302704, MEF1302804, MEF1302904, MEF1303004, MEF1303104, MEF1303204, MEF1303304, MEF1303404, MEF1303504, MEF1303604, MEF1303704, MEF1303804, MEF1303904, MEF1304004, MEF1304104, MEF1304204, MEF1304304, MEF1304404, MEF1304504, MEF1304604, MEF1304704, MEF1304804, MEF1304904, MEF1305004, MEF1305104, MEF1305204, MEF1305304, MEF1305404, MEG1300104, MEG1300204, MEG1300304, MEG1300404, MEG1300504, MEG1300604, MEG1300704, MEG1300804, MEG1300904, MEG1301004, MEG1301304, MEG1301404, MEG1301504, MEG1301604, MEG1301704, MEG1301804, MEG1301904, MEG1302004, MEG1302104, MEG1302204, MEH1300104, MEH1300204, MEH1300304

Recalling Firm/
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 you choose to use the optional SYS/DIAS mode, the values on the CAM01 display will be reversed. 2. Complete the attached form. If you do not have the product with the affected serial number in service at your facility, check the box: I do not have any product with a serial number of the form MExxxxxx04. 3. If you do have the affected serial number, check the box: I do have the product with a serial number of the form MExxxxxx04, and please indicate the serial numbers you have. 4. Complete the other information and return it by email or fax as indicated on the form. Complete the form and return it by email or fax as indicated on the form. Should you have any questions regarding these instructions, please contact Customer Service at 1-855-532-1723. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GWM and Original Applicant = CAMINO NEUROCARE, INC.