FDA Medical Device Recalls (openFDA)
Hill-Rom Manufacturing, Inc.: Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.
- Recall number
- Z-1875-2009
- Recalling firm
- Hill-Rom Manufacturing, Inc.
- Product
- Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.
- Status
- Terminated
- Initiated
- 2009-05-12
- Posted
- 2009-08-03
- Terminated
- 2012-04-03
- Reason
- The devices may emit smoke from the blower box assembly.
- 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
- 889 units
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- 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.
- 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
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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