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Terminated

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

FDA Recall Z-1401-06 · Posted 2006-08-11

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2006-07-07
Date Terminated2008-03-26
Product Quantity23 units

Reason for Recall

Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format.

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution --- USA and countries including Australia, China, Denmark, Germany, New Zealand, Portugal, Russia, Singapore, South Africa, Sweden and Switzerland

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981313SEQUENCERImpac Medical Systems, Inc. · 1998-07-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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