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