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Argus II Clinician Fitting System(CFS)
- Starting date:
- September 26, 2016
- 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-60588
Affected Products
Reason
Software (Device Identifier 014003-005-R, Version #2.14.2.16214) was unable to program a left eye implant (Device Identifier 011016-001-K) the day prior to surgery at a site in the US.
Affected products
Argus II Clinician Fitting System(CFS)
Lot or serial number
V009080
Model or catalog number
014003-055-R
Companies
- Manufacturer
-
Second Sight Medical Products, Inc.
12744 San Fernando Road, Building 3
Sylmar
91342
California
UNITED STATES