InTouch Software Repair Kit (2019-10-29)

Starting date:

October 29, 2019

Posting date:

November 22, 2019

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-71670

Last updated: 2019-11-22

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  Reason
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  Affected products

Affected Products

InTouch Software Repair Kit

Reason

Via customer complaints and subsequent non-conformance review [March 2019], it has been identified that the audible bed exit alarm is affected by a software issue in the footboard that prevents users from being able to change the alarm volume. The impacted footboard software is REV_0665-C. If a user attempts to adjust the bed exit alarm volume, the slider may indicate that it is set to high volume, however, the audible alarm will sound at the low volume setting. The volume then cannot be changed by the user

Affected products