Heidelberg Engineering recalls SPECT: A non-contact ophthalmic diagnostic device with HEYEX2 image management system that may display incorrect patient data due to a software configuration error.
Error in the default configuration which could lead to the incorrect display of patient master data.
Heidelberg Engineering is recalling SPECTRALIS ophthalmic diagnostic devices with HEYEX2 image management software because a default configuration error could cause incorrect patient data to be displayed. This may lead to misdiagnosis or treatment errors if the device is used without proper verification.
The device's default software configuration error can cause patient master data to be displayed incorrectly. This might lead to misdiagnosis or inappropriate treatment decisions if healthcare providers rely on the displayed data without verifying it.
Ophthalmologists and clinics using the SPECTRALIS with HEYEX2 image management system are affected. Patients receiving eye exams with this device may be at risk of misdiagnosis if the software displays incorrect patient data.
The recalled product is the SPECTRALIS ophthalmic diagnostic device with HEYEX2 image management system. It was sold with software version TFID-3439.
Verify if your device uses the HEYEX2 image management system with software version TFID-3439.
The device may display incorrect patient data due to a software configuration error, but it is not unsafe to use. Users should verify patient data before making clinical decisions.
Check if your device uses the HEYEX2 image management system with software version TFID-3439. If so, you may need to update the software configuration to prevent incorrect data display.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Heidelberg Engineering to request your refund or repair — edit it as you like.
Subject: Recall Z-2437-2019 — Heidelberg Engineering Heidelberg Engineering Hello, I own a Heidelberg Engineering that is covered by recall Z-2437-2019 from Heidelberg Engineering. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
