CS 8100 and CS 8100 3D (2015-01-27)

Starting date:

January 27, 2015

Posting date:

February 6, 2015

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-43633

• Reason
• Affected products

Recalled products

1. CS 8100
2. CS 8100 3D

Reason

Carestream has identified an issue related to the manufacturing process of CS 8100 and CS 8100 3D tomographic digital panoramic x-ray systems, manufactured between June 2012 and September 2014, which could result in the head unit descending unexpectedly and contacting the patient. The issue was found at an installation and nobody was injured. It has been determined that the root cause was a circlip (retaining clip) on a pin used to mate the lower and upper portions of the stand not being fitted at the time of manufacture. This allowed the locating pin to move out of position within the location hole during transportation. There is no hazard during transport and the issue would now be found at any new installation. Testing has shown that even without both circlips fitted, the pin does not fall out during use, but could move, therefore to ensure all installed devices are not affected and will perform as designed through their expected life, a field inspection recall is being initiated.

Affected products