Artis zee and Artis zeego systems. x-ray, angiographic system
FDA device recall Z-2569-2014 · posted 2014-09-22 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 206
- Distribution
- Nationwide Distribution
- Date initiated
- 2014-06-05
- Date posted
- 2014-09-22
- Date terminated
- 2015-04-21
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ZEE AND ZEEGO (K073290) | Siemens Medical Solutions USA, Inc. | 2008-02-11 |