Z-0929-04

Concha IV Plus Heated Humidifier

Name: Z-0929-04 Concha IV Plus Heated Humidifier
Creator: Hudson Respiratory Care Inc
Published: 2004-04-20
License: https://open.fda.gov/license/

Hudson Respiratory Care, Inc. / initiated 2004-04-20 / Terminated / root cause: software

FDA source

Hudson Respiratory Care Inc began a recall of Concha IV Plus Heated Humidifier on 2004-04-20. The reason FDA records is "Software malfunction. The humidifier did not retain the clinician selected default settings for temperature gradient, after the unit had been placed in the "pause" mode". 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-0929-04
Status: Terminated
Initiated: 2004-04-20
Posted: 2004-07-20
Terminated: 2005-01-18
Recalling firm: Hudson Respiratory Care, Inc.
Product: Concha IV Plus Heated Humidifier
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall: Software malfunction. The humidifier did not retain the clinician selected default settings for temperature gradient, after the unit had been placed in the "pause" mode.
Root cause tag: software
FDA root cause: Other
Action: Firm will call hospitals to arrange for a visit to update the software.
Quantity in commerce: 1049
Distribution: Nationwide.
Product codes and lots: All products manufactured with software 11738 -rev.03, Version V13.6, 252 A. This represents all units currently in the field.

Product code BTT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)