Home / Recalls / Heidelberg Engineering GmbH / Z-2437-2019

Z-2437-2019 Class II Terminated

Recalled by Heidelberg Engineering GmbH — Heidelberg, N/A

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