SpatialFrame.com Software (2018-03-19)

Starting date:

March 19, 2018

Posting date:

May 1, 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-66630

• 
  Reason
• 
  Affected products

Affected products

SpatialFrame.com Software

Reason

In rare circumstances, when surgeons use the software to plan the strut adjustment, an "inverted" image of the frame is generated by the software. This situation is easily recognizable.

Affected products