The US Food and Drug Administration (FDA) announced a Class II recall for Heidelberg Engineering GmbH’s Spectralis with Flex Module. Heidelberg Engineering voluntarily initiated the ongoing recall because wheels may come loose when the module is being pushed or pulled during movement or transportation, potentially affecting the stability of the stand and causing it to tip over. The company said a falling stand could cause impact or crushing injuries, particularly to the feet, legs, hands, or arms of the operator or nearby persons.

In an Urgent Field Safety Notice for SPECTRALIS Users, Heidelberg Engineering advised users to ensure that all caster wheels are properly aligned and to move the device only when necessary. If the wheels are tilted or leaning, users should not move the stand until the problem has been corrected. The company also advised customers to schedule a service appointment with a Heidelberg Engineering service partner as soon as possible to have the caster fastenings inspected and, if necessary, corrected.

The FDA lists the product quantity as 87. The recall was initiated on August 6 and classified as Class II by the FDA on September 18.

The affected devices include Spectralis with Flex Module models S3610, S2610, S2000, and S1610, a multimodal imaging platform optimized for the posterior segment of the eye. The devices were distributed in Massachusetts and internationally in Australia, Austria, Canada, Costa Rica, Czech Republic, France, Germany, India, Israel, Italy, Mexico, Netherlands, Philippines, Poland, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, United Kingdom, and Vietnam.

The recall number is Z-3215-2026. The UDI-DI is 04059237000235. Affected lot codes are Spec-07265, Spec-11121, Spec-11281, Spec-12096, Spec-13305, Spec-14403, Spec-15282, Spec-15587, Spec-20071, Spec-20348, Spec-20351, Spec-20591, Spec-20605, Spec-23473, Spec-23941, Spec-23950, Spec-23975, Spec-24507, Spec-24558, Spec-24582, and Spec-24611. OM