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Health product recall

Discovery IGS (2014-01-12)

Starting date:
January 12, 2015
Posting date:
January 21, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-43369

Recalled Products

Discovery IGS

Reason

Systems may experience an unintentional motion or rotation due to a positioning user interface issue. The potential reversed motion of the gantry/table has been observed when the user positions the joystick at its maximum position (end of travel) on the smart box. The unintended reversal of the direction of the motion may lead to a collision of the table or C-arm with medical instruments, patient or personnel, and result in injury.

Affected products

Discovery IGS

Lot or serial number

AM12P3D241

Model or catalog number

S18631BA (5418812)

Companies
Manufacturer
GE Medical Systems SCS
283 Rue De La Miniere
Buc
78530
FRANCE