Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Desktop Pro R6.0 & R6.1, Linear Medical Accelerator.

FDA Recall Z-0421-2007 · Posted 2007-02-07

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2006-11-23
Date Terminated2008-05-14
Product Quantity37 units

Reason for Recall

Unexpected Diaphragm movement when manual field size modifications are not saved.

Firm Action

Consignees were notified by letter on/about 11/23/2006

Root Cause

Software design

Distribution Pattern

Worldwide distribution ---- including USA states of AZ, AL, CA, CO, FL, GA, IA, MI, NV, OH, OK, PA, WA, WV and Country of Canada .

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982713RT DESKTOPElekta Oncology Systems, Ltd. · 1998-11-02

Official Source

View FDA Recall →

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

↑