inforMED
MalfunctionLEJ

SUNDASH

Received May 23, 2014 · Event occurred May 21, 2014

Report 2311923-2014-00002 · MDR key 3878044

Device

Generic name

Radius

Model number

252

Product problems

  • Electrical /Electronic Property Problem
  • Electrical Shorting

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

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

Description of Event or Problem

WIRING IN POWER HARNESS SHORTED.

Remedial action

  • Recall