Health product recall

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

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

InTouch Software Repair Kit

Lot or serial number

All lots.

Model or catalog number

27-2893K

Companies
Manufacturer

Stryker Medical

3800 E Centre Avenue

Portage

49002

Michigan

UNITED STATES