Z-1939-2018 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-1939-2018 was initiated by Siemens Medical Solutions USA, Inc on Apr 20, 2018 and is designated Class II. Reason for recall: There is a potential for a software issue that may cause the need for necessary patient rescans. The recall status is terminated (terminated May 23, 2019). Affected quantity: 4 units in US.

Recall Details

Product Type
Devices
Report Date
Jun 6, 2018
Initiation Date
Apr 20, 2018
Termination Date
May 23, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 units in US

Product Description

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

Reason for Recall

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

Distribution Pattern

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.

Code Information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1939-2018
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.