Allura XPER Systems (2017-03-17)

Starting date:

March 17, 2017

Posting date:

April 13, 2017

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-62998

• Reason
• Affected products

Affected Products

1.  Allura XPER FD10/10-Main Unit
2.  Allura XPER FD20/10 System-Main Unit
3.  Allura XPER FD10
4.  Allura XPER FD20 System-Main Unit
5.  Allura XPER FD20 OR Table
6. Allura XPER FD10 (Product of Alluraclarity Family)
7. Allura XPER FD20/20 (Product of Alluraclarity Family)

Reason

Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the r-cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

Affected products