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Health product recall

Leksell Gamma Knife Perfexion (2014-10-06)

Starting date:
October 6, 2014
Posting date:
October 10, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-41739

Recalled Products

Leksell Gamma Knife Perfexion

Reason

We have got a report that the latches may be locked before they have been fully turned, resulting in a poorly locked frame. Investigations show that it may be possible to have a situation where the adapter latches can get stuck just above the coordinate frame surface and as a result the coordinate frame will not be fixed properly.

Affected products

Leksell Gamma Knife Perfexion

Lot or serial number

Not applicable

Model or catalog number

715000

Companies
Manufacturer

Elekta InstrumentS AB

Kungstensgatan 18,

Stockholm

10393

SWEDEN