Cios Alpha, mobile X-ray system
FDA device recall Z-1278-2016 · posted 2016-03-31 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Software issues on Cios Alpha mobile C-Arm system
- Action taken
- Siemens sent an Customer Safety Advisory Notice on February 26, 2016, to inform them of some issues that may arise on the Cios Alpha unit. The letter identified the product the problem and the action needed to be taken by the customer. Users were instructed to change the date format to DDMMYYYY to prevent issues, not to release radiation as long as the DVD icon is blinking and to disconnect and re-connect the trolley if the system is needed immediately. In the meantime they are preparing a modification of Cios Alpha that will resolve the above-mentioned issues. As soon as the modification is available, a service engineer will get in touch with each customer and implement the modification to the Cios Alpha system free of charge. If the device was sold, customers were instructed to forward the recall notification to the new owner. For further questions please call (610) 448-6478.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 89 systems
- Distribution
- Nationwide Distribution to the states of : AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA and WI
- Date initiated
- 2016-02-19
- Date posted
- 2016-03-31
- Date terminated
- 2017-03-20
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CIOS ALPHA (K132094) | Siemens Medi Cal Solutions, Inc. | 2014-03-11 |