Heidelberg SPECTRALIS Ophthalmic Imaging Device Recalled for Data Display Error
Heidelberg Engineering is recalling 29 SPECTRALIS ophthalmic imaging devices because a software configuration error may cause incorrect display of patient master data.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect display of patient data, which is a significant software defect but does not involve a direct physical injury mechanism or reported harm, fitting the criteria for a moderate severity recall.
Plain-English summary
Heidelberg Engineering GmbH is recalling 29 units of the SPECTRALIS with HEYEX2 image management system, a non-contact ophthalmic diagnostic imaging device. The recall is due to an error in the default configuration that could lead to the incorrect display of patient master data.
The affected devices were distributed nationwide in the United States. The recall covers all software versions with the HEYEX2 image management system, identified by TFID-3439. The source text does not specify the number of reported injuries or illnesses associated with this defect.
Healthcare providers and consumers should contact Heidelberg Engineering GmbH for instructions on how to resolve the configuration error. The source text does not provide specific contact details or remediation steps beyond the recall notice itself.
The recalled product
- Product
- SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
- Manufacturer
- Heidelberg Engineering GmbH
- Affected units
- 29
Distribution
Distributed nationwide across the United States.
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