Z-1875-2009

Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores

Name: Z-1875-2009 Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores
Creator: Hill-Rom Manufacturing, Inc.
Published: 2009-05-12
License: https://open.fda.gov/license/

Hill-Rom Manufacturing, Inc. / initiated 2009-05-12 / Terminated / root cause: manufacturing process

FDA source

Hill-Rom Manufacturing, Inc. began a recall of Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores on 2009-05-12. The reason FDA records is "The devices may emit smoke from the blower box assembly". 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-1875-2009
Status: Terminated
Initiated: 2009-05-12
Posted: 2009-08-03
Terminated: 2012-04-03
Recalling firm: Hill-Rom Manufacturing, Inc.
Product: Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.
Product code: IOQ Bed, Flotation Therapy, Powered
Reason for recall: The devices may emit smoke from the blower box assembly.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Urgent Field Safety Notice letter dated May 11, 2009. Hill-Rom service centers were notified by letter on 05/13/2009. Action to be taken are as follows: Rental Customers; In the next 60 days, Hill Rom will be removing the Flexicair II and Flexicair MC3 low Airloss Therapy Units from service to correct the devices. During that time, Hill-Rom may provide an equivalent substitute therapy to accommodate the patients who continue to need a pressure reducing therapy device. If t his malfunction occurs before a substitution or a corrected device is provided, unplug the device, remove the patient from the surface and notify Hill-Rom immediately. Facility-Owned Customers: In the next 60 days, for all facility owned Flexicair II and Flexicair MC3 Low Airloss Therapy Units, a Hill-Rom service technician will either replace the affected components in the blower assembly or deliver an equivalent substitute unit from Hill-Rom's rental fleet. If this malfunction occurs before the device is corrected or a substitute provided, do as follows: unplug the device, remove the patient from the surface, and immediately notify Hill-Rom Technical Support using the attached listing their geographical region.
Quantity in commerce: 889 units
Distribution: Nationwide and Canada
Product codes and lots: All serial numbers. The prefix "IC" is representative of a Flexicair¿ MC3 and a six digit number without a prefix is representative of a refurbished Flexicair¿ MC3.

Product code IOQ

K863047Class IIFlexicairSsi Medical Services, Inc. / cleared 1986-09-05

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)