Z-2437-2019 Class II Terminated
FDA device recall Z-2437-2019 was initiated by Heidelberg Engineering GmbH on July 3, 2019 and is designated Class II. Reason for recall: Error in the default configuration which could lead to the incorrect display of patient master data. The recall status is terminated (terminated November 2, 2020). Affected quantity: 29.
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2019
- Initiation Date
- July 3, 2019
- Termination Date
- November 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29
Product Description
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 Pattern
US nationwide distribution
Code Information
All software versions with HEYEX2 image management system Identification: TFID-3439