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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Siemens Medical Solutions USA, Inc
Reason for Recall:
There is a potential for a software issue that may cause the need for necessary patient rescans.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1939-2018

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During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

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During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

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ARTIS Pheno VE30A and VE40A, Model 10849000

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During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

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