510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1080-2014Class II

Siemens Artis zee Ceiling Systems. Angiographic x-ray system

Siemens Medical Solutions USA, Inc. / initiated 2013-12-16 / Terminated / root cause: design

Siemens Medical Solutions USA, Inc began a recall of Siemens Artis zee Ceiling Systems. Angiographic x-ray system on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1080-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
Product code
IZI System, X-Ray, Angiographic
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.
Root cause tag
design
FDA root cause
Device Design
Action
In December 2013, a recall notification letter was sent to Users.
Quantity in commerce
284
Distribution
Nationwide Distribution.
Product codes and lots
Artis zee Ceiling systems serial numbers from 146352 to 147617

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1080-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1080-2014Class IITerminatedVoluntary: Firm initiated