FDA recall Z-2437-2019
Heidelberg Engineering GmbH · Class II · device
Product
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Reason for recall
Error in the default configuration which could lead to the incorrect display of patient master data.
Distribution
US nationwide distribution
Key facts
- Status
- Terminated
- Initiation date
- 2019-07-03
- Report date
- 2019-09-11
- Termination date
- 2020-11-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Heidelberg, N/A, Germany
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2437-2019