Heidelberg Engineering GmbH recalls Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Mod…

Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.

Firm began notifying US customers on August 6, 2026 via email. Instruction to Customers: There is a possibility that the castor wheels of the Flex stand are not properly attached. The wheels may come loose when the Flex Module is being pulled or pushed during movement or transportation, affecting the stability of the stand. As a result, the Flex stand may tip over if not correctly handled or supported by the operator. Users shall schedule a service appointment with your Heidelberg Engineering service partner as soon as possible so that the castor fastenings can be inspected and, if necessary, corrected.

• FDA enforcement recordOfficial FDA database entry for Z-3215-2026
• FDA 510(k) clearance · K181594The device's official FDA premarket clearance record
• FDA device classification · OBOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.1570The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Heidelberg Engineering GmbHSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.