The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configur

FDA device recall Z-0486-2015 · posted 2014-12-01 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the "Block Radiation" key on the touch screen control. If this behavior occurs, the system image generation function is not available for patient examinations without switching the system off and back on again manually. This

Action taken

Siemens sent an Important Customer Safety Notice in September 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the fault described above occurs, we urgently recommend switching the system OFF manually ("System shutdown") and then back ON again. The fault cannot generally be rectified sufficiently, either by executing the "System Restart" or "Application Restart" functions. A corresponding supplement to the Operator Manual is enclosed with this letter. The problem will be solved when the next Service Update is available (currently scheduled for 2014). We thank you for your cooperation in dealing with this safety notice and request that you promptly notify and instruct accordingly all the staff at your organization who have to be aware of this problem. Please also forward this safety information to other organizations that could be affected by this measure. Please observe this safety notice, and comply with the corresponding measures until the update has been fully completed. If this device has been sold and is therefore no longer in your possession, please forward this safety notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. For further questions please call (610) 219-6300.

Root cause

Device Design

Status

Terminated

Product code

IZI

Quantity affected

1131

Distribution

Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of: United Arab Emirates, Armenia, Austria, Australia, Belgium, Bahrein ,Belarus, Switzerland, Chile, China, Colombi

Date initiated

2013-09-11

Date posted

2014-12-01

Date terminated

2015-03-30

Location

Malvern, PA

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