The Recall Desk

Manufacturer

Heidelberg Engineering GmbH

1 recall in our database name Heidelberg Engineering GmbH as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2019-09-11

Of the 1 recalls from Heidelberg Engineering GmbH we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • ModerateFDA (Devices)·Z-2437-2019·2019-09-11

    Heidelberg SPECTRALIS Ophthalmic Imaging Device Recalled for Data Display Error

    Heidelberg Engineering is recalling 29 SPECTRALIS ophthalmic imaging devices because a software configuration error may cause incorrect display of patient master data.

    Product
    SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
    Category
    Medical Device
    Distribution
    Distributed nationwide