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Callisto Eye 3.0 and 3.1 (2014-07-29)
- Starting date:
- July 29, 2014
- Posting date:
- July 22, 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-59504
Affected products
A. Callisto Eye 3.0 and 3.1
Reason
Carl Zeiss CALLISTO eye assistance with software version 3.0 or 3.1 material number 301640-3010-300. During our continuous internal testing we found a software error when switching between day and night mode. This error disables some of the assistant functions and could lead to poor refractive outcome.
Affected products
A. Callisto Eye 3.0 and 3.1
Lot or serial number
7028208
7028209
7028210
Model or catalog number
CALLISTO EYE 3.0
CALLISTO EYE 3.1
Companies
- Manufacturer
-
Carl Zeiss Meditech AG
Goeschwitzer Strasse 51-52
Jena
07745
GERMANY