Home / Recalls / Medical Devices
Haag-Streit USA Inc recalls EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Recalled March 29, 2017 · FDA recall Z-1500-2017 · Haag-Streit USA
Hazard
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow. · FDA Class II
Units
163 units
Sold at
US Nationwide distribution.
Description
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
Product
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Manufacturer(s)
Haag-Streit USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →