Z-1401-06

LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface

Name: Z-1401-06 LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface
Creator: Siemens Medical Solutions USA, Inc
Published: 2006-07-07
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2006-07-07 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface on 2006-07-07. The reason FDA records is "Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format". 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-1401-06
Status: Terminated
Initiated: 2006-07-07
Posted: 2006-08-11
Terminated: 2008-03-26
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format.
Root cause tag: software
FDA root cause: Software design
Action: The firm has issued a safety advisory letter to all affected consignees, and will distribute an updated software version as soon as it is available.
Quantity in commerce: 23 units
Distribution: Worldwide Distribution --- USA and countries including Australia, China, Denmark, Germany, New Zealand, Portugal, Russia, Singapore, South Africa, Sweden and Switzerland
Product codes and lots: Site Numbers: 93-0452, 93-0494, 93-0571, 93-0724, 93-0881, 93-0894, 93-0902, 93-0443, 93-0776, 93-0677, 93-1032, 93-0880, 93-0010, 93-0095, 93-0432, 93-0991, 93-0711, 93-0007, 93-0641, 93-0356, 93-0391, 93-0015, 93-0118

Product code IYE

K981313Class IISequencerImpac Medical Systems, Inc. / cleared 1998-07-09

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)