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Pentax Medical Endoscopes (2017-07-17)
- Starting date:
- July 17, 2017
- Posting date:
- August 14, 2017
- 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-64158
Affected Products
- Slim Cystoscope Set
- Pentax Vb-2000 Video Bronchoscope
- E.N.T. Scope
Reason
Pentax Medical has become aware that some customers may own legacy endoscopes where the screw connecting the suction arm to the control body could loosen with time. A loose suction arm may result in inadequate suctioning due to leakage of air. There is also the potential for organic debris to accumulate in the space between the suction nipple and control body. In some cases, these events could cause cross-contamination between patients.
Affected products
-
Slim Cystoscope Set
Lot or serial number
- G110026
- G110030
- G110031
- G110036
- G110041
- G110042
- G110046
- G110050
Model or catalog number
ECY-1570K
Companies
- Manufacturer
-
Hoya Corporation
6-10-1 NISHI-SHINJUKU
Shinjuku-ku
160-0023
JAPAN
B. Pentax Vb-2000 Video Bronchoscope
Lot or serial number
G110017
G110029
G110123
G110458
G110589
G110907
G111020
G111021
Model or catalog number
EB-117OK
EB-1570K
EB-1970K
EB-1970TK
Companies
- Manufacturer
-
Hoya Corporation
6-10-1 NISHI-SHINJUKU
Shinjuku-ku
160-0023
JAPAN
C. E.N.T. Scope
Lot or serial number
G110059
G110117
Model or catalog number
VNL-1570STK
Companies
- Manufacturer
-
Hoya Corporation
6-10-1 NISHI-SHINJUKU
Shinjuku-ku
160-0023
JAPAN