Haag-Streit USA Inc recalls EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
- Recall date
- January 5, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1500-2017
- FDA classification
- Class II
- Brand / firm
- Haag-Streit USA Inc
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Get recall alerts
Free email alert whenever Haag-Streit USA Inc has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Haag-Streit USA Inc