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[Recalled] Medical Linear Accelerator — There have been instances in hospitals where the joint between the drive gear a… | FDA 2016-07-08

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductMedical Linear Accelerator
Brand / manufacturerElekta, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2721-2016
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date08 July 2016

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

This Class II recall concerns device products distributed in United States 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 Elekta, Inc.

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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