Recall Z-1500-2017— Haag-Streit USA Inc
Class II · Terminated
Class II FDA medical device recall by Haag-Streit USA Inc, initiated 2017-01-05, terminated 2019-03-22. It names one FDA 510(k) clearance: K142423. Product: EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).. Reason: There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow..
- Recalling firm
- Haag-Streit USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-05
- Terminated
- 2019-03-22
- Firm location
- Mason, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Reason for recall
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
Data sourced from openFDA. This site is unofficial and independent of the FDA.