Advanced Perfusion System 1 - EPGS Service Manual (2018-11-10)

Starting date:

November 10, 2018

Posting date:

November 30, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68480

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  Reason
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  Affected products

Affected products

Advanced Perfusion System 1 - EPGS Service Manual

Reason

This notice is to clarify the Terumo Advanced Perfusion System 1 service manual for the Electronic Patient Gas System (EPGS), catalog # 875306. The service manual (rev. E) states that the oxygen sensor expiration alert is triggered at 300,000 %-hours, whereas the EPGS software (version 1.30) presents an alert message and prevents calibration of the EPGS when the oxygen sensor has reached 100,000 %-hours, which accurately reflects the oxygen sensor design specification.  The Terumo System 1 Service Manual (EPGS) discrepancy is limited to service documentation only.

Affected products