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Innova E4 and E5 CMS (2017-06-14)
- Starting date:
- June 14, 2017
- Posting date:
- July 7, 2017
- 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-63882
Affected Products
A. Innova E4 CMS
B. Innova E5 CMS
Reason
This recall is being initiated by the manufacturer to reduce the chance of a blockage and improve the flow of water and chemical through the nozzle within the unit that would connect the 7th channel in a 7-channel scope to the Innova unit. The size of this nozzle is currently 0.2 mm and it will be replaced by a 0.5 mm nozzle.
Affected products
A. Innova E4 CMS
Lot or serial number
59742001
59742002
59742003
59742004
60361001
60361002
60361003
Model or catalog number
50600.92
50600.93
E4-CMS
E4CMS-DH
Companies
- Manufacturer
-
BHT HYGIENETECHNIK GMBH
MESSERSCHMITTSTRASSE 11
GERSTHOFEN
86368
GERMANY
B. Innova E5 CMS
Lot or serial number
68881001
68881002
68881003
68881004
69880001
69880002
69880003
Model or catalog number
50600.94
50600.95
50600.96
50600.97
E5-CMS
E5CMS-DC-EFF
E5CMS-DH
E5CMS-DH-EFF
Companies
- Manufacturer
-
BHT HYGIENETECHNIK GMBH
MESSERSCHMITTSTRASSE 11
GERSTHOFEN
86368
GERMANY