ITS4850A IntelliVue Telemetry System - MONITOR (2018-11-11)

Starting date:

November 11, 2018

Posting date:

November 28, 2018

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-68424

• 
  Reason
• 
  Affected products

Affected products

ITS4850A IntelliVue Telemetry System - MONITOR

Reason

The volume of the MX40 speaker in these devices may be diminished or not audible above 4,500 feet when operating in monitor mode. These devices may intermittently exhibit Speaker Malfunct INOP messages after the power on self-test.

Affected products