Ultrasonic Gastrovideoscopes (2020-10-20)
- Starting date:
- October 20, 2020
- Posting date:
- April 8, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75327
Last updated:
2021-04-08
Affected Products
A. ENDOSCOPIC ULTRASOUND SYSTEM EU-M30
B. EUS EXERA ENDOSCOPIC ULTRASOUND SYSTEM
C. EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND SYSTEM-ULTRASOUND GASTROVIDEOSCOPE
D. OLYMPUS ULTRASONIC GASTROVIDEOSCOPES FOR ALOKA ULTRASOUND PROCESSORS
E. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
Reason
OMSC is issuing validated, revised instructions for use with the referenced EUS endoscopesafter an investigation indicated a potential risk of infection due to residual blood and foreignmatter in the air/water channel of the Convex Ultrasound endoscopes. Additional modelswith a similar structure are included in this recall.
Affected products
A. ENDOSCOPIC ULTRASOUND SYSTEM EU-M30
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
GF-UMQ130
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
B. EUS EXERA ENDOSCOPIC ULTRASOUND SYSTEM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
GF-UM160
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
C. EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND SYSTEM-ULTRASOUND GASTROVIDEOSCOPE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
GF-UC160P-OL5
GF-UCT160-OL5
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
D. OLYMPUS ULTRASONIC GASTROVIDEOSCOPES FOR ALOKA ULTRASOUND PROCESSORS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
GF-UC140P-AL5
GF-UCT140-AL5
GF-UE160-AL5
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
E. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
GF-UCT180
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN