Z-0106-04

Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT

Name: Z-0106-04 Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
Creator: Cti Pet Systems Inc
Published: 2003-10-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-10-02 / Terminated

FDA source

Cti Pet Systems Inc began a recall of Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT on 2003-10-02. The reason FDA records is "CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0106-04
Status: Terminated
Initiated: 2003-10-02
Posted: 2003-11-13
Terminated: 2006-02-07
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.
FDA root cause: Other
Action: Written notification was sent out beginning 10/02/2003 to distributors and end users to advise them of the problem.
Quantity in commerce: 73
Distribution: Nationwide International: Japan, Germany, Brazil, Spain, China, Russia, Austrailia, Hong Kong, Singapore, Poland France, Korea, Greece, UK and Austria
Product codes and lots: All CPS manufactured PET/CT systems distributed between October 31, 2000 and June 24, 2003.

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)