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Rigid Endoscopes
- Starting date:
- January 25, 2017
- Posting date:
- February 27, 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-62374
Reason
Pentax America Inc. is issuing new instructions for use (IFU) for two rigid Laryngostroboscope models 9106 and 9108. This new IFU clarifies the reprocessing instructions in order to ensure that customers are aware of the best methods for cleaning their 9106 and 9108 endoscopes.
Affected products
Rigid Endoscopes
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
9106
9106
9108
9108
Companies
- Manufacturer
-
Pentax of America, Inc.
3 Paragon Drive
Montvale
07645
New Jersey
UNITED STATES