Z-0270-2008

Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc...

Name: Z-0270-2008 Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc...
Creator: Siemens Medical Solutions USA Inc
Published: 2007-07-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-07-23 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA Inc began a recall of Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA... on 2007-07-23. The reason FDA records is "Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0270-2008
Status: Terminated
Initiated: 2007-07-23
Posted: 2007-11-29
Terminated: 2009-09-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.
Root cause tag: software
FDA root cause: Software design
Action: Siemans sent an Urgent Device Correction letter, dated June 15, 2007, to all affected consignees informing the user of the problem and requesting that they discontinue the practice of running all transmissions followed by all emissions until a corrective software patch is installed. The corrective software patch is expected to be installed by October 2007.
Quantity in commerce: 43 units
Distribution: Worldwide Distribution - USA and Countries of Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Japan, South Korea, Netherlands, Norway, Saudi Arabia, Sweden, Slovak Republic, Turkey, and Taiwan.
Product codes and lots: Serial Numbers: 3600066-00-0001001, 3600066-00-0001002, 3600066-00-0001005, 3600066-00-0001007, 3600066-00-0001008, 3600066-00-0001010, 3600066-00-0001013, 3600066-00-0001014, 3600078-00-0001003, 3600082-00-0001002, 3600084-00_0001005, 3600084-00-0001005, 3600090-00-0001001, 3600090-00-0001002, 3600090-00-0001003, 3600090-00-0201005, 3600090-00-0201006, 3600099-00-001001, 3600099-00-001006, 3600099-00-001009, 3600099-00-0201002, 3600099-00-0201003, 3600099-00-0201004, 3600099-00-0201005, 3600099-00-0201007, 3600099-00-0201008, 3600099-00-0201010, 3600099-00-0201012, 3600099-00-0301013, 3600099-00-0301014, 3600099-00-0301016, 3600099-00-0301017, 3600099-00-0301018, 3600099-00-0301019, 3600099-00-0301020, 3600099-00-0301021, 3600099-00-0301022, 3600099-00-0301023, 3600099-00-0301024, 3600099-00-0301025, 3600099-00-0301026, 3600099-00-0301027, 3600099-00-0301028

Product code KPS

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)