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
- Other Reasons
- 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.
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
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Heidelberg Engineering
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|---|---|---|---|---|---|
| Device | CLASS II | GmbH Spectralis with Flex Module recalled by Heidelberg Engineering | Heidelberg Engineering | Potency & Assay | Nationwide |
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Other Imaging Equipment recalls
All 2,341| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips EPIQ Elite Diagnostic Ultrasound System recalled | Philips Ultrasound | Labeling Errors | Nationwide |
| Device | CLASS II | GmbH Spectralis with Flex Module recalled by Heidelberg Engineering | Heidelberg Engineering | Potency & Assay | Nationwide |
| Device | CLASS II | Core Services Hub V8, a set of backend services including recalled | GE Healthcare | Other | Nationwide |
| Device | CLASS II | Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Haylard Univ Imaging Biopsy Trucustom kits recalled by Avid Medical | Avid Medical | Sterility | 4 states |