CLASS II Device recall · Reported 11 Sep 2019 · FDA Enforcement Report
Spectralis with HEYEX2 image management system recalled
Heidelberg Engineering is recalling Spectralis with HEYEX2 image management system, distributed nationwide in the US. The recall was initiated on 3 Jul 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2437-2019
- FDA event ID
- 83568
- Recalling firm
- Heidelberg Engineering, Heidelberg, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jul 2019
- FDA classified
- 30 Aug 2019
- Reported
- 11 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Imaging Equipment
Timeline
| 3 Jul 2019 | Recall initiated by company | |
| 30 Aug 2019 | Classified by FDA | +58 days |
| 11 Sep 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Error in the default configuration which could lead to the incorrect display of patient master data.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Where it was distributed
US nationwide distribution
Questions about this recall
Is Spectralis with HEYEX2 image management system recalled?
Yes. Heidelberg Engineering recalled Spectralis with HEYEX2 image management system on 3 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2437-2019.
Why was it recalled?
Error in the default configuration which could lead to the incorrect display of patient master data.
Which lots are affected?
All software versions with HEYEX2 image management system Identification: TFID-3439
Where was it sold?
US nationwide distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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