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[Recalled] DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002) — Potential of compromised compatibility resulting in influence on the positionin… | FDA 2025-03-14

recall fda device germany

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductDORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Brand / manufacturerPro-Med Instruments Gmbh
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1860-2025
Country of noticeGermany
Risk levelClass II
Hazard typerecall
Notice date14 March 2025
EAN / barcode04250435506738

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.

This Class II recall concerns device products distributed in Germany and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Pro-Med Instruments Gmbh

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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