Spirit Bed (2018-10-08)

Starting date:

October 8, 2018

Posting date:

October 26, 2018

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-68086

• Reason
• Affected products

Affected products

Spirit Bed

Reason

In March 2018, during manufacture testing, Stryker medical became aware that Spirit Select and Plus (models 5600 and 5700) with high rail siderail option produced starting Jan 2, 2013 are incorrectly labeled indicating compliance to bed standard IEC 60601-2-52/C1:2010. However, high rail configured beds are compliant to bed standard IEC 60601-2-38 Amd 1. Ed 1.0 en:1999.

Affected products