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Terminated

Siemens Artis zee Ceiling Systems. Angiographic x-ray system.

FDA Recall Z-1080-2014 · Posted 2014-02-24

Recall StatusTerminated
Product CodeIZI
Date Initiated2013-12-16
Date Terminated2015-03-09
Product Quantity284

Reason for Recall

During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.

Firm Action

In December 2013, a recall notification letter was sent to Users.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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