Aeroneb Pro AC/DC Adapter and Aeroneb Pro X Controller (2014-09-02)

Starting date:

September 2, 2014

Posting date:

September 25, 2014

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-41511

• Reason
• Affected products

Recalled products

1. Aeroneb Pro AC/DC Adapter
2. Aeroneb Pro X Controller

Reason

Aerogen has received a small number of complaints in relation to the mains power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser Systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. However it cannot be ruled out that the adapter may fail during use. If the failure were to occur during use then the internal electrical components of the mains power adapter would become exposed to the user. Therefore, there is a potential risk of electric shock if the cover falls off during use, with mains power turned on, and the user makes contact with specific recessed components inside the adapter housing.

Affected products