Z-1263-2009

Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use

Name: Z-1263-2009 Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use
Creator: Draeger Medical, Inc.
Published: 2009-01-21
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2009-01-21 / Terminated / root cause: software

FDA source

Draeger Medical, Inc. began a recall of Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use on 2009-01-21. The reason FDA records is "The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1263-2009
Status: Terminated
Initiated: 2009-01-21
Posted: 2009-05-14
Terminated: 2010-01-05
Recalling firm: Draeger, Inc.
Product: Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery.
Root cause tag: software
FDA root cause: Software design
Action: An "Urgent - Medical Device Recall" Letter dated January 2009 was issued to consignees via certified mail. The letter described the issue, specific conditions, background information, and precautions for customers. An additional letter dated January 22, 2009 was included with the "Urgent - Medical Device Recall" letter which instructed consignees to inform an enduser of the contents of the notification letter because some of the consignees are home care device/service providers. When the new hardware/software solution is available, affected devices will be updated free of charge. Direct questions about the notification letter to Drager Medical, Inc. by calling 1-800-543-5047 (press "1" at the prompt and then press "2349#"). Direct questions regarding updating your device when the new software is available, contact Drager Service Technical Support at 1-800-543-5047 (press "4" at the prompt).
Quantity in commerce: 40 units
Distribution: Nationwide Distribution -- states of CA, FL, GA, HI, IL, LA, MA, MN, OH, and TX.
Product codes and lots: Catalog Numbers 5704757 and 5704758.

Product code CBK

K060705Class IICarina HomeDraeger Medical B.V. / cleared 2006-06-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)