Reported Sep 11, 2019 · Terminated
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Heidelberg Engineering GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heidelberg Engineering GmbH · Tiergartenstr. 15 · Heidelberg, N/A · N/A
Is this the product you have?
- SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
- Lot codes and dates
- All software versions with HEYEX2
- image management system IdentificationTFID-3439
- Amount recalled
- 29
Where it was sold
- Nationwide
Why it was recalled
Error in the default configuration which could lead to the incorrect display of patient master data.
This product could cause temporary or reversible health problems — stop using it.
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