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Terminated

Artis zee and Artis zeego systems. x-ray, angiographic system

FDA Recall Z-2569-2014 · Posted 2014-09-22

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2014-06-05
Date Terminated2015-04-21
Product Quantity206

Reason for Recall

There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can become blocked unnecessarily.

Firm Action

Siemens sent an "Important Customer Safety Notice" dated August 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please forward this Safety information to other organizations that could be affected by this measure. If the device has been sold and 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. Please observe this Customer Safety Notice and comply with the corresponding measures until the update has been fully completed. For further questions please call (610) 219-6300.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K073290ARTIS ZEE AND ZEEGOSiemens Medical Solutions USA, Inc. · 2008-02-11

Official Source

View FDA Recall →

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

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