FDA Medical Device Recalls (openFDA)
Hill-Rom Manufacturing, Inc.: 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.
- Recall number
- Z-0058-04
- 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.
- Status
- Terminated
- Initiated
- 2003-08-27
- Posted
- 2003-10-24
- Terminated
- 2004-07-01
- Reason
- Reports of patient entrapment between mattress and side-rails.
- 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
- 515 units
- Distribution
- Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.
- Lot, serial or model codes
- Model #13000, IBxxxxxx (where xxxxxxx is a 6-digit number sequence)
- 510(k) numbers
- ["K863047"]
- PMA numbers
- not on file
- Product code
- IOQ
- Firm FEI
- 1045510
- Firm city
- Charleston
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28