Z-0058-04

FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above...

Name: Z-0058-04 FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above...
Creator: Hill-Rom Manufacturing, Inc.
Published: 2003-08-27
License: https://open.fda.gov/license/

Hill-Rom Manufacturing, Inc. / initiated 2003-08-27 / Terminated

FDA source

Hill-Rom Manufacturing, Inc. began a recall of FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR... on 2003-08-27. The reason FDA records is "Reports of patient entrapment between mattress and side-rails". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0058-04
Status: Terminated
Initiated: 2003-08-27
Posted: 2003-10-24
Terminated: 2004-07-01
Recalling firm: Hill-Rom Manufacturing, Inc.
Product: FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.
Product code: IOQ Bed, Flotation Therapy, Powered
Reason for recall: Reports of patient entrapment between mattress and side-rails.
FDA root cause: Other
Action: Consignees were notified by letter on 08/27/2003. They were alerted to the potential for patient entrapment. Modification of the units were to be conducted at the rental service center, or the sight where the unit is currently located. The consignee would be contacted to arrange for the modification to be installed on the rental if it is at their location when the modification is scheduled for the unit. If the consignee purchased the bed, they would be contacted by a Hill Rom service representative to arrange to install the modification.Enclosed with the letter is information regarding, Tips For Reducing the Risk of Patient Entrapment.
Quantity in commerce: 515 units
Distribution: Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.
Product codes and lots: Model #13000, IBxxxxxx (where xxxxxxx is a 6-digit number sequence)

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)