FDAClass IIJune 6, 2018

SOMATOM go.Now recall: Software Issue

SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.

Why was SOMATOM go.Now recalled?

There is a potential for a software issue that may cause the need for necessary patient rescans.

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?

Serial Numbers: 106041, 106051, 106052, 106053, 106054, 106055, 106056, 106057, 106058, 106059, 106060, 106061, 106062, 106065, 106066, 106067, 106068, 106069, 106070, 106071, 106072, 106073, 106074, 106075, 106077, 106078, 106079, 106080, 106081, 106082, 106083, 106084, 106085, 106086, 106087, 106088, 106089, 106090, 106091, 106092, 106093, 106094, 106095, 106096, 106097, 106098, 106099, 106100, 106101, 106102, 106103, 106104, 106105, 106106, 106107, 106108, 106109, 106110, 106111, 106112, 106113, 106114, 106115, 106116, 106117, 106118, 106119, 106120, 106121, 106122, 106123, 106124, 106125, 106126, 106127, 106128, 106129, 106130, 106131, 106132, 106133, 106134, 106135, 106136, 106137, 106138, 106139, 106140, 106141, 106142, 106143, 106144, 106145, 106146, 106147, 106148, 106149, 106150, 106151, 106152, 106153, 106154, 106155, 106156, 106157, 106158, 106159, 106160, 106161, 106162, 106163, 106164, 106165, 106166, 106167, 106168, 106169, 106170, 106171, 106172, 106173, 106174, 106175, 106176, 106177, 106178, 106179, 106180, 106181, 106182, 106183, 106184, 106185, 106186, 106187, 106188, 106189, 106190, 106191, 106192, 106193, 106194, 106195, 106196, 106197, 106198, 106199, 106200, 106201, 106202, 106203, 106204, 106205, 106206, 106207, 106208, 106209, 106210, 106211, 106212, 106213, 106214, 106215, 106216, 106217, 106218, 106219, 106220, 106221, 106222, 106223, 106224, 106225, 106226, 106227, 106228, 106229, 106230, 106231, 106232, 106233, 106234, 106235, 106236, 106237, 106238, 106239, 106240, 106241, 106242, 106243, 106244, 106245, 106246, 106247, 106248, 106249, 106250, 106251, 106252, 106253, 106254, 106255, 106256, 106257, 106258, 106259, 106260, 106261, 106262, 106263, 106264, 106265, 106266, 106267, 106268, 106269, 106270, 106271, 106272, 106273, 106274, 106275, 106276, 106277, 106278, 106279, 106280, 106281, 106282, 106283, 106284, 106285, 106286, 106287, 106288, 106289, 106290, 106291, 106292, 106293, 106294, 106295, 106296, 106297, 106298, 106299, 106300, 106301, 106302, 106303, 106304, 106305, 106306, 106307, 106308, 106309, 106310, 106311, 106312, 106313, 106314, 106315, 106316, 106317, 106318, 106319, 106320, 106321, 106322, 106323, 106324, 106325, 106326, 106327, 106328, 106329, 106330, 106331, 106332, 106333, 106335, 106336, 106337, 106340, 106341, 106342, 106343, 106345, 106347, 106348, 106349, 106350

Product
SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
4 units in US
Distribution
Worldwide Distribution: US (nationwide) including states of: AR, CA, CT, FL, GA, IL, IN, KS, KY, MO, ND, NY, OH, OK, SD, TN, TX, and VA; and countries of: Algeria, Australia, Austria, Bangladesh, Bolivia, Bosnia Herzog., Brazil, Cambodia, Chile, China, Columbia, Costa Rica, Germany, Greece, India, Indonesia, Italy, Japan, Kenya, Kuwait, Lithuania, Mauritius, Morocco, Nepal, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic Korea, Romania, Senegal, Singapore, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, Ukraine, and United Kingdom.
Recall date
June 6, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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