[Recalled] Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. — CareFu

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Carefusion 211 Inc dba Carefusion

• Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. — Class I
• TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. — Class I
• AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. — Class I
• CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. — Class I
• AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. — Class I
• Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by deliveri — Class I

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.