• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Integra

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Integra see related information
Date Posted December 27, 2013
Recall Status1 Terminated 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/
Manufacturer
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact
855-532-1723
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GWM and Original Applicant = CAMINO NEUROCARE, INC.
-
-