Health product recall

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

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

Advanced Perfusion System 1 - EPGS Service Manual

Lot or serial number

0396
1338
1339
1340
1360
1361
1367
1396
1398

Model or catalog number

875306

Companies
Manufacturer
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES