Automated Field Steam Sterilizer (2021-08-19)

Starting date:

August 19, 2021

Posting date:

October 1, 2021

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-76563

Last updated:
2021-10-01

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  Reason
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  Affected products

Affected Products

Automated Field Steam Sterilizer

Reason

FDI has determined through internal testing on august 11th 2021, that the rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground. To be fully compliant with the electrical standard ul 61010-1 2nd edition, section 6.5.2.4, All metal components accessible by the user must have an impedance to ground of 0.1 Ohms or less. In the unlikely event of a damaged or faulty wire within the rear heater assembly, the rear heater plate and cover assembly could potentially become energized.

Affected products