Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-00727-1 |
Product Name/Description |
InTouch Critical Care Bed
Item Number: 2156000000
All lots affected
ARTG Number: 202755 (cancelled 21 March 2014) |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
4/07/2014 |
Responsible Entity |
|
Reason/Issue |
Stryker has received complaints from the field regarding InTouch beds, which allege that a caster has broken on the top of the caster stem where the brake rod inserts into the caster. These broken casters are identified when the InTouch beds are hoisted or lifted from the floor during regular maintenance. If more than one caster on a unit is damaged, brake functions may be affected and result in reduced brake holding force. If only one caster on the bed is damaged, brake functionality continues to meet specifications. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
A Stryker representative will perform an onsite inspection to determine if casters are affected. If affected the casters will be replaced. End users are reminded to not use the electronic brake to slow or stop the bed while it is in motion. |
Contact Information |
1800 803 601 - Stryker South Pacific |