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Health product recall

Carl Zeiss Forum 3.1 and Forum 3.2 (2015-02-01)

Starting date:
February 1, 2015
Posting date:
February 1, 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-62048

Affected Products

A. Forum 3.1

B. Forum 3.2

Reason

A software defect was identified that may cause the incorrect display of optical coherence tomography (OCT) scans (B-scans) in the forum viewer versions 3.1 and 3.2 which may lead to misinterpretation of OCT exam data.

Affected products

A. Forum 3.1

Lot or serial number

000000-2030-683

Model or catalog number

FORUM 3.1

Companies
Manufacturer

Carl Zeiss Meditech AG

Goeschwitzer Strasse 51-52

Jena

07745

GERMANY



B. Forum 3.2

Lot or serial number

000000-2094-705

Model or catalog number

FORUM 3.2

Companies
Manufacturer

Carl Zeiss Meditech AG

Goeschwitzer Strasse 51-52

Jena

07745

GERMANY