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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Sensation Open

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 Class 2 Device Recall SOMATOM Sensation Opensee related information
Date Initiated by FirmFebruary 15, 2016
Create DateMarch 31, 2016
Recall Status1 Terminated 3 on December 07, 2016
Recall NumberZ-1307-2016
Recall Event ID 73477
510(K)NumberK040577 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductSiemens 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 Open - 8872017
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactMarlynne 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
ActionA 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 Commerce124 units
DistributionUS (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 CycleTPLC Device Report

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.
510(K) Database510(K)s with Product Code = JAK
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