FDA Medical Device Recalls (openFDA)
Hill-Rom Manufacturing, Inc.: Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.
- Recall number
- Z-0484-2021
- Recalling firm
- Hill-Rom Manufacturing, Inc.
- Product
- Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.
- Status
- Terminated
- Initiated
- 2020-11-12
- Posted
- not on file
- Terminated
- 2022-11-10
- Reason
- Under certain conditions, there is a risk for fire.
- Root cause
- Process control
- Action
- The recalling firm is contacting all impacted consignees to notify of the recall. A response form is included with the customer notification. Consignees are requested to return the response form as proof of receipt of the mailing. Phone call follow-ups will commence if a response form is not received in a timely manner. A Hillrom representative will be contacting patients to schedule a time to come to your home to deliver a new Life2000 Ventilator to you and return your current device to Hillrom. Should you hear an audible hissing sound inside of the ventilator, this may indicate a gas leak inside ventilator. If you hear the audible hissing described, please discontinue use and contact Hillrom Customer Service immediately.
- Quantity
- 67 devices
- Distribution
- US Nationwide distribution including in the states of AR, AZ, CA, DE, FL, IL, IN, KY, MN, NC, NM, NV, NY, OH, OK, TX, UT, VA, VT, WI.
- Lot, serial or model codes
- Devices with the following Serial Numbers: 120210000731, L2004034-154, 120210000716, L1905010-080, 120210000750, 120190000086, 120190001268, 120210000885, 120190000724, 120190001234 120190001276, 120210000732, L1911019-029, 120210000761, L2002011-094, 120210000747, 120210000760, 120210000730, 120210000734, 120190000076 120190000079, 120190000081, 120190000090, 120190000714, 120190000722, 120190000074, 120190000077, 120190000728, 120210001608, 120210000742, 120210000755, L2001006-040, 120210000733 L1911019-035, 120210000744, 120210001613, 120210001614, 120210000714 L1903102-021, 120190001269, 120210000743, 120210000741, L1912010-015, 120210000753, 120210000739, 120190000088, 120190000711, 120190000718 120190001264, 120210001615, L1903102-012, L2001016-045, 120190000078 120190000089, 120190001266, 120210000884, 120190000091, 120190000093, 120190000707, 120210000729, L1903103-006, L1912010-005 L1912013-033, L2002040-095, L2002040-064, L2002040-093, L2003004-106
- 510(k) numbers
- ["K170037"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2183816
- Firm city
- Saint Paul
- Firm state
- MN
- 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