Z-0819-05

ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile...

Name: Z-0819-05 ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile...
Creator: CTI PET Systems Inc
Published: 2005-04-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2005-04-05 / Terminated

FDA source

CTI PET Systems Inc began a recall of ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by... on 2005-04-05. The reason FDA records is "Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0819-05
Status: Terminated
Initiated: 2005-04-05
Posted: 2005-05-11
Terminated: 2009-09-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit.
FDA root cause: Other
Action: Written notification via certified US Mail was sent out beginning 04/05/2005 to distributors and end users (with whom CTI had a service contract) to advise them of the problem.
Quantity in commerce: 80 units
Distribution: Nationwide, Canada, the Netherlands, Ireland & Denmark
Product codes and lots: Model Number: 3600079-00 Serial numbers: 0001013, 0001014 Model Number: 3600088-00 Serial numbers: 0001010, 0001016, 0001017, 0001019, 0001021, 0001023, 0001027, 0001029, 0001030, 0001031, 0001038, 0001041, 0001048, 0001051, 0001053, 0001054 Model Number: 3600097-00 Serial numbers: 0101004, 0101019, 0101025, 0101033, 0201041, 0201049, 0201053, 0201063 Model Number: 3600211-00 Serial numbers: 0101007, 0101016, 0101018, 0201023, 0201048, 0201050, 0201058, 0201064, 0201072, 0301082, Marketed under Siemens Model Number: 3600211-00 0101002, 0101004, 0101015, 0101014, 0101020, 0101021, 0201029, 0201028, 0201035, 0201062, 0201059, 0201063, 0201070, 0301110 Model Number: 3600079-00 Serial numbers: 0001010, 0001011, 0001018 Model Number: 3600085-00 Serial numbers: 0001001, 0001002 Model Number: 3600088-00 Serial numbers: 0001003, 0001006, 0001020, 0001035, 0001036, 0001043, 0001045, 0001044, 0001056, 0001062 Model Number: 3600097-00 Serial numbers: 0101016, 0101018, 0101030, 0201036, 0201040, 0201060 Model Number: 3600211-00 Serial numbers: 0201033, 0201034, 0201067, 0301108 Model Number: 3600099-00 Serial numbers: 0301024 Model Number: 3600088-00 Serial numbers: 001058 Model Number: 3600097-00 Serial numbers: 0101034, 0201038, 0201061

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)