Z-1903-2009

CLINITRON UP-LIFT" Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development...

Name: Z-1903-2009 CLINITRON UP-LIFT" Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development...
Creator: Hill-Rom Manufacturing, Inc.
Published: 2009-06-24
License: https://open.fda.gov/license/

Hill-Rom Manufacturing, Inc. / initiated 2009-06-24 / Terminated / root cause: manufacturing process

FDA source

Hill-Rom Manufacturing, Inc. began a recall of CLINITRON UP-LIFT" Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a... on 2009-06-24. The reason FDA records is "Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1903-2009
Status: Terminated
Initiated: 2009-06-24
Posted: 2009-08-25
Terminated: 2012-07-11
Recalling firm: Hill-Rom Manufacturing, Inc.
Product: CLINITRON UP-LIFT" Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.
Product code: INX Bed, Air Fluidized
Reason for recall: Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Hill-Rom issued an "Urgent Field Safety Notice" letter dated February 2, 2009 addressed to Facility Risk Managers and Facility Administrators. The notice detailed the issue and instructed users on actions to be taken. For further information, please contact Hill-Rom Customer Service at 1-800-638-2546.
Quantity in commerce: 625 units (total both units)
Distribution: Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico, Saudi Arabia, Singapore, Taiwan, Turkey and Venezuela.
Product codes and lots: All serial numbers.

Product code INX

K920112Class IIClinitron C-IISupport Systems Intl. / cleared 1992-01-24

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)