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Terminated

Leksell Gamma Knife C

FDA Recall Z-1533-2010 · Posted 2010-04-29

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIWB
Date Initiated2006-09-01
Date Terminated2010-12-14
Product Quantity88 units

Reason for Recall

Leksell Gamma Knife C 1.2 with MCU version 4.0.0.6 improperly adjusted trolley for 4mm helmet caused jamming when helmet changer attempted to lock helmet. Lock did not fully engage and could still be raised. When the lock does not engage, then when the helmet changer rises, the helmet could disengage from the helmet changer and fall back onto the helmet trolley.

Firm Action

Phase 1 - Field Change Order FCO-DOC-06-0003 "Technical Note - Potential risk of dropping the collimator helmet" (dated Aug. 28, 2006) was sent to affected customers as notification of the problem. Phase 2 - Technical Notes Leksell Gamma Knife C version 1.2 (dated July 2006) "Important Notice - Potential risk of dropping the collimator helmet" was sent to all Elekta Service Engineers as notification of the problem. The firm planned to create an upgrade kit for the effected Leksell Gamma Knife C1.2 systems. A service representative from Elekta will contact each site to decide on a suitable implementation schedule.

Root Cause

Other

Distribution Pattern

Nationwide, Austria, Belgium, Canada, China, Croatia, Italy, Japan, Korea, Norway, Spain, Sweden, Taiwan and Turkey.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984328LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001Elekta Instrument AB · 1999-05-21

Official Source

View FDA Recall →

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

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