Heidelberg Engineering GmbH: Medical Device Recall in 2019 - (Recall #: Z-2437-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.

Product Classification:

Class II

Date Initiated: July 3, 2019

Date Posted: September 11, 2019

Recall Number: Z-2437-2019

Event ID: 83568

Reason for Recall:

Error in the default configuration which could lead to the incorrect display of patient master data.

Status: Terminated

Product Quantity: 29

Code Information:

All software versions with HEYEX2 image management system Identification: TFID-3439

Distribution Pattern:

US nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated