Z-0161-05

SOMATOM CT System Sensation Cardiac (+ Straton), Computed Tomography X-Ray System, Model Numbers 75 43 106

Name: Z-0161-05 SOMATOM CT System Sensation Cardiac (+ Straton), Computed Tomography X-Ray System, Model Numbers 75 43 106
Creator: Siemens Medical Solutions USA, Inc
Published: 2004-09-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2004-09-28 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM CT System Sensation Cardiac (+ Straton), Computed Tomography X-Ray System, Model Numbers 75 43 106 on 2004-09-28. The reason FDA records is "Calcium Scoring feature on this devices is not closing properly after patient's exams". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0161-05
Status: Terminated
Initiated: 2004-09-28
Posted: 2004-11-03
Terminated: 2008-09-04
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM CT System Sensation Cardiac (+ Straton), Computed Tomography X-Ray System, Model Numbers 75 43 106
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Calcium Scoring feature on this devices is not closing properly after patient's exams.
FDA root cause: Other
Action: The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
Quantity in commerce: 47 units
Distribution: The product was shipped to medical facilities nationwide and government account in IL.
Product codes and lots: Serial Numbers: 52948, 52950, 52951, 52952, 52953, 52954, 52955, 52956, 52957, 52958, 52959, 52960, 52961, 52962, 52963, 52964, 52965, 52966, 52967, 52968, 52969, 52971, 52972, 52973, 52974, 52975, 52976, 52977, 52978, 52979, 52980, 52981, 52982, 52983, 52984, 52985, 52986, 52988, 52989, 58990, 52991, 52992, 52993, 52994, 52996, 52997, and 58999

Product code JAK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)