FORMULA THERAPY SYSTEMS (2016-10-17)

Starting date:

October 17, 2016

Posting date:

October 28, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-60786

• Reason
• Affected products

Affected Products

Reason

This voluntary field corrective action is being taken on the formula family of hemodialysis machines following reports of three thermal events which led to fire, involving three different machines in the field. No patients or healthcare providers were injured as a result of these events. Preliminary investigations indicate that the battery charge board was the source of two of the events. Due to extensive damage on the machine, the source of the third event is difficult to conclude. Investigation into the trigger for the events is on-going. This recall involves all machines manufactured and imported since 1998. The corrective action will involve disconnection of the battery charge board to eliminate the possibility of the failure mode while a permanent solution is implemented.

Affected products