SPECTRALIS with HEYEX2 image management system. a recall
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Why was SPECTRALIS with HEYEX2 image management system. a recalled?
Error in the default configuration which could lead to the incorrect display of patient master data.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All software versions with HEYEX2 image management system Identification: TFID-3439
- Product
- SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
- Recalling firm
- Heidelberg Engineering GmbH
- Quantity
- 29
- Distribution
- US nationwide distribution
- Recall date
- September 11, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)