Device Recall SOMATOM Sensation 10 의 리콜

Recall

79428

Class 2

Z-1453-2018

2018-02-15

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162298

To inform customers of possible incorrect tube current calculations by the care dose4d algorithm for head scans based on p.A. (posterior-anterior) or a.P. (anterior-posterior) topograms. depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure.

The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 1301 units will consist of the following: 1. You will contact customers and initiate the actions to correct the failure to comply issue. 2. You will provide a software update to correct tube current calculations by the CARE Dose4D algorithm for head scans. 3. You will follow-up with consignees to verify the effectiveness of the software update. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. You may proceed or continue with implementation of the CAP (subject to the conditions noted above). For further questions, please call (610) 219-4834.