RegWardenFDA facility compliance records
Company

Heidelberg Engineering GmbH

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

Recalls by year

FDA actions on record by year2017: 1 recalls; 2019: 1 recalls; 2026: 1 recalls1201720181201920202021202220232024202512026
  • Recalls (3)

Registered facilities (1)

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…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Heidelberg Engineering GmbH — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9003668-heidelberg-engineering-gmbh/

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