Recall Z-2437-2019— Heidelberg Engineering GmbH

Name: FDA recall Z-2437-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-03

Class II · Terminated

Class II FDA medical device recall by Heidelberg Engineering GmbH, initiated 2019-07-03, terminated 2020-11-02. It names one FDA 510(k) clearance: K181594. Product: SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.. Reason: Error in the default configuration which could lead to the incorrect display of patient master data..

Recalling firm: Heidelberg Engineering GmbH
Classification: Class II
Status: Terminated
Initiated: 2019-07-03
Terminated: 2020-11-02
Firm location: Heidelberg, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K181594 — Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH·cleared 2018-09-13

K-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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.