FDAClass IIJune 3, 2015

SOMATOM Perspective recall: Software Issue

SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray…

Why was SOMATOM Perspective recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
75
Distribution
Nationwide Distribution including Puerto Rico.
Recall date
June 3, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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