Z-1675-2009

Somatom Definition Model AS/AS+, Model number 8098027

Name: Z-1675-2009 Somatom Definition Model AS/AS+, Model number 8098027
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-05-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-05-29 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Somatom Definition Model AS/AS+, Model number 8098027. Intended use: Computed Tomography X-ray system on 2009-05-29. The reason FDA records is "Support mechanism may not engage properly due to improper stowage after opening which may result in internal component damage or potential injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1675-2009
Status: Terminated
Initiated: 2009-05-29
Posted: 2009-07-30
Terminated: 2009-09-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Somatom Definition Model AS/AS+, Model number 8098027. Intended use: Computed Tomography X-ray system
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Support mechanism may not engage properly due to improper stowage after opening which may result in internal component damage or potential injury.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The firm has issued a modification of the telescope support arm parking bracket via Update Instruction CT028/09/S. A firm service representative will install the modified support arm parking brackets on the affected systems.
Quantity in commerce: 93 units
Distribution: Nationwide Distribution -- including states of AR, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, MA, MD, MN, MO, MT, NC, ND, NE, NH, NY, OH, PA, SC, SD, TN, VA, WA, WI, and WY.
Product codes and lots: Serial numbers: 63241, 64009, 64014, 64064, 64065, 64067, 64068, 64071, 64074, 64077, 64078, 64079, 64081, 64082, 64085, 64087, 64091, 64097, 64103, 64104, 64105, 64112, 64113, 64114, 64115, 64117, 64118, 64122, 64123, 64138, 64140, 64142, 64145, 64154, 64164, 64168, 64169, 64170, 64171, 64172, 64177, 64178, 64179, 64180, 64181, 64189, 64190, 64194, 64199, 64202, 64212, 64214, 64228, 64231, 64232, 64235, 64236, 64239, 64243, 64244, 64245, 64246, 64248, 64253, 64258, 64259, 64260, 64261, 64263, 64270, 64271, 64272, 64273, 64274, 64278, 64282, 64284, 64289, 64290, 64291, 64293, 64296, 64297, 64308, 64310, 64314, 64328, 64337, 64340, 64342, 64347, 64352, and 64354.

Product code JAK

K081022Class IISomatom Definition, Model As/as+Siemens Medical Solutions USA, Inc. / cleared 2008-06-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)