inforMED
MalfunctionLEJ

SUNDASH

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

Report 2311923-2014-00001 · MDR key 3899084

Device

Generic name

Radius

Model number

252

Product problems

  • Device Issue

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WIRING IN POWER HARNESS SHORTED.

Additional Manufacturer Narrative

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

Remedial action

  • Recall