Aerogen Ltd.: The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.

Recall number

Z-0121-2015

Recalling firm

Aerogen Ltd.

Product

The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.

Status

Terminated

Initiated

2014-09-02

Posted

2014-10-23

Terminated

2016-04-25

Reason

Aerogen has received a small number of complaints in relation to the main 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.

Root cause

Nonconforming Material/Component

Action

URGENT FIELD SAFETY NOTICE letters dated September 2, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) compare their power adapter date codes against those found in the letter as being subject to this recall; 2) until new power adapters are received, customers may continue to use the recalled power adapters if the customer inspects each power adapter prior to use and finds that there is no evidence of damage or separation of the housing and unplug the adapter after each use; and, 3) contact the Aerogen or appropriate Aerogen sales partner immediately so that the power adapter can be replaced free of charge. The letter further requests that the recall notification be forwarded to any parties that may have received the recalled power adapters. Customers with questions can contact Aerogen at 866-423-76436.

Quantity

323 power adapters

Distribution

Worldwide Distribution-USA (nationwide) including the states of CA, GA, IL, MS, NC, and TX, and the countries of Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Lot, serial or model codes

FRIWO AC/DC Adapter Model Number: GPP10;   The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers:   1) Model Number: AG-UC1000-NE; Lot Numbers: 9263140718116 , 9263140718137 , 9263140730049;  2) Model Number: AG-UC1000-UK; Lot Numbers: 9235140718022 , 9235140718093 , 9235140718154;  3) Model Number: AG-UC1500-NE; Lot Numbers: 9264140627057 , 9264140627100 , 9264140721112 , 9264140724100;  4) Model Number: AG-UC1500-SC; Lot Numbers: 9277140721040;  5) Model Number: AG-UC1500-SE; Lot Numbers: 9276140731046

510(k) numbers

["K021175"]

PMA numbers

not on file

Product code

CAF

Firm FEI

3003399703

Firm city

Dangan Galway

Firm state

not on file

Firm country

Ireland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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