Z-1896-2016Class I

Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad...

Name: Z-1896-2016 Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad...
Creator: Carefusion 211 Inc dba Carefusion
Published: 2016-05-17
License: https://open.fda.gov/license/

Jaeger Medical GmbH / initiated 2016-05-17 / Terminated

FDA source

Carefusion 211 Inc dba Carefusion began a recall of Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a... on 2016-05-17. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1896-2016
Classification: Class I
Status: Terminated
Initiated: 2016-05-17
Posted: 2016-06-13
Terminated: 2017-09-28
Recalling firm: Jaeger Medical GmbH
Product: 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.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: 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).
FDA root cause: Under Investigation by firm
Action: CareFusion sent a Field Safety Notice dated May 17, 2016, to all affected customers. The notice informed customers that 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 malfunction creates a blank AVEA Ventilator UIM and INOP condition during pre-use check or during use with cessation of ventilation to the patient. By design an audible clinical alarm is activated. Customers were informed of the problems identified and the actions to be taken. Customers were not required to return the affected devices or suspend use, customers would receive an copy of the identified affected serial numbers, as well as a response card, customers were requested to promptly return the response card to expedite the correction process and acknowledge receipt of the notification, Customers would be contacted by CareFusion to arrange onsite remediation of the affected devices, in the interim if any AVEA ventilator unit in their facility exhibits a blank AVEA Ventilator UIM and INOP condition during pre-use check or during use with cessation of ventilation, immediately remove the ventilator from service, provide alternate ventilation and contact CareFusion Technical Support per the contact information listed below to report the issue. Customers with questions should call 888-562-6016, for technical support 800-231-2466 or [email protected].
Quantity in commerce: 922 units total (501 units in US)
Distribution: Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.
Product codes and lots: n/a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1896-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1888-2016	Class I	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13
Z-1889-2016	Class I	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13
Z-1890-2016	Class I	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13
Z-1891-2016	Class I	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13
Z-1892-2016	Class I	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13
Z-1893-2016	Class I	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13
Z-1894-2016	Class I	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13
Z-1895-2016	Class I	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13
Z-1896-2016	Class I	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13
Z-1897-2016	Class I	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13
Z-1898-2016	Class I	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13
Z-1899-2016	Class I	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13

Product code CBK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)