Neuro-Fiberscope (2019-08-23)
- Starting date:
- August 23, 2019
- Posting date:
- September 12, 2019
- 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-70961
Last updated: 2019-09-12
Affected Products
Neuro-Fiberscope
Reason
During a complaint investigation the device instruction manual was reviewed and an error was noticed. For Steris SS1 E process, the quick connector kit model number and the associated tray number listed in the manual were incorrect. A further step was taken to review all flexible scope instruction manuals and found the error in other manuals as well.
Affected products
Neuro-Fiberscope
Lot or serial number
All lots.
Model or catalog number
11161C2
11282BN1
Companies
- Manufacturer
-
KARL STORZ SE & CO. KG
DR.-KARL-STORZ STRASSE 34
TUTTLINGEN
78532
GERMANY