Date Initiated by Firm |
April 20, 2015 |
Date Posted |
May 22, 2015 |
Recall Status1 |
Terminated 3 on September 01, 2016 |
Recall Number |
Z-1646-2015 |
Recall Event ID |
71101 |
510(K)Number |
K133590
|
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product |
SOMATOM Perspective; the intended use of computed tomography is 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 angels or spiral planes taken at different angles.
|
Code Information |
SOMATOM Perspective - 10495568 with serial numbers: 59019 59195 59060 59043 59025 59029 59189 59204 76954 59010 59164 59185 59048 59169 77107 77110 59011 59030 59171 59168 59017 59167 59162 59190 59047 59061 77121 59028 59165 59020 59181 59037 59035 59005 59183 59016 59027 59184 76950 59203 59015 77182 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
|
For Additional Information Contact |
Customer Support 610-219-6300
|
Manufacturer Reason for Recall |
Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.
|
FDA Determined Cause 2 |
Software design |
Action |
Siemens sent an Customer Safety Advisory Notice dated April 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
A remote software update is scheduled for release that will resolve the issue. For further questions, please call (610) 219-6300. |
Quantity in Commerce |
75 |
Distribution |
Nationwide Distribution including Puerto Rico. |
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.
|
510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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