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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80047

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 20, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions USA, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-1939-2018
Recall number
Z-1939-2018
Initiated
April 20, 2018
Classification
Class II
Status
Terminated
Quantity
4 units in US

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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

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.

device · product 2 of 2

SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.

Z-1940-2018
Recall number
Z-1940-2018
Initiated
April 20, 2018
Classification
Class II
Status
Terminated
Quantity
33 units in US

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Numbers: 108052, 108053, 108054, 108055, 108056, 108057, 108058, 108059, 108060, 108061, 108062, 108063, 108064, 108065, 108066, 108067, 108068, 108069, 108070, 108071, 108072, 108073, 108074, 108075, 108076, 108077, 108078, 108079, 108080, 108081, 108082, 108083, 108084, 108085, 108086, 108087, 108088, 108089, 108090, 108091, 108092, 108093, 108094, 108095, 108096, 108097, 108098, 108099, 108100, 108101, 108102, 108103, 108104, 108105, 108106, 108107, 108108, 108109, 108110, 108111, 108112, 108113, 108114, 108115, 108116, 108117, 108118, 108119, 108120, 108121, 108122, 108123, 108124, 108125, 108126, 108127, 108128, 108129, 108130, 108131, 108132, 108133, 108134, 108135, 108136, 108137, 108138, 108139, 108140, 108141, 108142, 108143, 108145

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.