Heidelberg SPECTRALIS Flex Module Recall Due to Wheel Detachment Risk

Plain-English summary

Heidelberg Engineering GmbH is recalling 87 units of the SPECTRALIS with Flex Module (models S3610, S2610, S2000, and S1610). These multimodal imaging platforms are optimized for the posterior segment of the eye. The recall is due to a defect where the wheels on the Flex Module may come loose when the module is pushed or pulled during movement or transportation.

The detachment of the wheels affects the stability of the stand, which may cause the stand to tip over. A falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands, or arms of the operator or nearby persons. The affected units were distributed worldwide, including in the United States (specifically Massachusetts) and various international locations such as Australia, Canada, and Germany.

Healthcare facilities and users should stop using the affected Flex Modules immediately. They should contact Heidelberg Engineering GmbH for instructions on how to resolve the issue or obtain a replacement. The recall number is Z-3215-2026.

The recalled product

Product

Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye

Manufacturer

Heidelberg Engineering GmbH

Category

Medical Device — Ophthalmic Imaging

Hazard

• crushing-injury
• impact-injury
• equipment-failure

Affected units

87

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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