Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, N

FDA device recall Z-0602-2014 · posted 2013-12-27 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

GWM

Quantity affected

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,

Date initiated

2013-11-26

Date posted

2013-12-27

Date terminated

2015-02-13

Location

Plainsboro, NJ

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