Heidelberg Engineering Recalls Widefield OCT Software Feature for Spectralis Devices
Heidelberg Engineering is recalling the Widefield OCT software feature for Spectralis HRA+OCT devices because FDA determined a 510(k) clearance is required before use.
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: This is a regulatory compliance recall (missing 510(k) clearance) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Heidelberg Engineering is recalling the Widefield OCT software feature for the Spectralis HRA+OCT and variants. The recall involves 382 units distributed nationally. The software feature was available on SPECTRALIS Software US versions 6.3 to 6.8a and requires the Widefield Objective Module accessory and a dedicated license to operate.
The recall was initiated after the U.S. Food and Drug Administration notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature. On November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked the company to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained.
Customers who have the Widefield OCT software feature should stop using it immediately and contact Heidelberg Engineering for further instructions regarding the pending clearance.
The recalled product
- Product
- Widefield OCT software feature for the Spectralis HRA+OCT and variants
- Manufacturer
- Heidelberg Engineering
- Affected units
- 382
Distribution
Distribution scope not specified by the agency.
Related recalls
Same hazard · regulatory non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
Similar recalls
- ModerateHeidelberg SPECTRALIS Ophthalmic Imaging Device Recalled for Data Display Error
FDA (Devices) · 2019-09-11
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- ModerateCIRRUS HD-OCT Model 6000 imaging devices recalled for missing FDA pre-market clearance
FDA (Devices) · 2021-08-18
- HighVITROS 5600 Diagnostic System Software Defect Prevents Quality Control Flagging
FDA (Devices) · 2024-03-13
- ModerateCIRRUS HD-OCT Optic Nerve Angiography Feature Requires Deactivation
FDA (Devices) · 2022-03-16
- HighSpectral CT Devices Pose Collision and Misdiagnosis Software Risks
FDA (Devices) · 2024-12-11