Facility

HEIDELBERG ENGINEERING GMBH

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002807157
Establishment type	Manufacture Medical Device
Location	Max-Jarecki-Str. 8 HEIDELBERG Baden-Wurttemberg, DE 69115
Registration status	Active · expires 2026
Parent company	Heidelberg Engineering GmbH (owner-operator 9003668)
Brand names	ANTERION

Activity by year

Recalls (3)

Devices registered here (1)

Tomography, Optical Coherence
Product code OBO (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.1570

Recalls & enforcement

Class IIOngoing2026-08-06
Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator …
Class IITerminated2019-07-03
Error in the default configuration which could lead to the incorrect display of patient master data.
Class IITerminated2017-12-08
FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked Heidelberg Engineering to instruct customers not to use the W…

All facilities operated by Heidelberg Engineering GmbH

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “HEIDELBERG ENGINEERING GMBH (FEI 3002807157) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807157-heidelberg-engineering-gmbh/

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