inforMED
MalfunctionJAF

ELITE PROBE

Received Jun 29, 2017 · Event occurred Jun 7, 2017

Report 3010611950-2017-00042 · MDR key 6678857

Device

Generic name

Elite 3mhz Probe

Model number

X1L001

Catalog number

N300

Lot number

N/A

Product problems

  • Device Sensing Problem
  • Device Sensing Problem

Patient

0 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

REFERENCE NATUS (B)(4). THERE HAVE BEEN NO REPORTED INJURIES. REFERENCE FIELD CORRECTIVE ACTION NUMBER 3010611950/06/09/2017/001-R.

Description of Event or Problem

EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.

Remedial action

  • Recall