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[Recalled] Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors. — Potential for clinical errors |

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductStereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
Brand / manufacturerElekta, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0138-2014
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date23 July 2013

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Potential for clinical errors.

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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