Artis zee and Artis zeego systems. x-ray, angiographic system
This recall has been terminated (originally issued September 22, 2014).
- Recall Initiated
- June 5, 2014
- Posted
- September 22, 2014
- Terminated
- April 21, 2015
- Recall Number
- Z-2569-2014
- Quantity
- 206
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution
Lot / Code Info
running software version VC21B 10094135, 10094137, 10094141, 10280959 with multiple serial numbers .
Root Cause
Software design
Action Taken
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.