HFA Review (accessory of Humphrey Field Analyzer 3 (HFA3)) (2019-09-06)
- Starting date:
- September 6, 2019
- Posting date:
- September 6, 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-70903
Last updated: 2019-09-11
Affected Products
HFA Review (accessory of Humphrey Field Analyzer 3 (HFA3))
Reason
HFA review software version 1.0.1 which is compatible with HFA 830, 840, 850 and 860 models can possibly cause loss of test results/medical record information leading to a delay in treatment. There is a potential for a delay of treatment that could result in minor deterioration in a patient's vision (loss of less than a line on a visual acuity chart). The HFA review software is an accessory to the HFA instrument and the HFA instrument is not affected.
Affected products
HFA Review (accessory of Humphrey Field Analyzer 3 (HFA3))
Lot or serial number
Not applicable.
Model or catalog number
HFA 830
HFA 840
HFA 850
HFA 860
Companies
- Manufacturer
-
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin
94568
California
UNITED STATES