ITS4850A IntelliVue Telemetry System - Monitor (2019-03-25)

Starting date:

March 25, 2019

Posting date:

May 3, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69810

Last updated: 2019-05-03

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  Reason
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  Affected products

Affected Products

ITS4850A IntelliVue Telemetry System - Monitor

Reason

Problem 1

some MX4O patient worn monitors may have excessive battery power consumption. For those MX4O's with revision B software and fully charged batteries may last approximately 25% shorter than is specified in the MX4O instructions for use. This issue affects units operating on both rechargeable and disposable batteries.

Problem 2

Low battery technical alerts may not occur as specified in the instructions for use.

For those MX4O's that:

1) operate with disposable AA batteries, and

2) include optional SP02 used in automatic measurement mode.

The technical alerts that may be absent include:

- "TELE BATTERY LOW",

- "NO SPO2T: BATT LOW",

- "REPLACE TELE BATTERY"

Affected products