| Class 2 Device Recall SOMATOM Sensation 64/ Cardiac64 | |
Date Initiated by Firm | February 15, 2016 |
Create Date | March 31, 2016 |
Recall Status1 |
Terminated 3 on December 07, 2016 |
Recall Number | Z-1305-2016 |
Recall Event ID |
73477 |
510(K)Number | K040665 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. |
Code Information |
Model Number: SOMATOM Sensation 64/ Cardiac 64 - 8377520 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact | Marlynne Galloway 610-448-6471 |
Manufacturer Reason for Recall | Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio licenses "Cardio Pro" and "Cardio Retro". |
FDA Determined Cause 2 | Device Design |
Action | A Safety Advisory Notice was sent to customers informing them of a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems. Siemens informed them that they will deliver an Update Instruction for their Service Engineers to modify the installed Firmware. This will correct the rare synchronization errors of Scanner Firmware and Scanner Software to start the application of the x-ray in compliance with the optimum triggering point for best image quality. |
Quantity in Commerce | 124 units |
Distribution | US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JAK
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