inforMED
MalfunctionLEJ

SUNDASH

Received Oct 30, 2012 · Event occurred Oct 24, 2012

Report 2311923-2012-00019 · MDR key 2856210

Device

Generic name

Radius 252

Model number

RADIUS 252

Product problems

  • Electrical Shorting

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WIRING IN A POWER HARNESS SHORTED.

Additional Manufacturer Narrative

AN 806 SUBMITTED TO THE (B)(4) DISTRICT OFFICE OF THE FDA.

Remedial action

  • Recall