Z-0484-2021Class II

Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 -

Name: Z-0484-2021 Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 -
Creator: Hill-Rom Manufacturing, Inc.
Published: 2020-11-12
License: https://open.fda.gov/license/

Hill-Rom Manufacturing, Inc. / initiated 2020-11-12 / Terminated / root cause: manufacturing process

FDA source

Hill-Rom Manufacturing, Inc. began a recall of Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings... on 2020-11-12. FDA classified it as Class II and gives the reason as "Under certain conditions, there is a risk for fire". 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-0484-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-12
Posted: 2020-11-24
Terminated: 2022-11-10
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.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Under certain conditions, there is a risk for fire.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0484-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0484-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-24

Product code CBK

K170037Class IIBreathe Technologies Life2000™ Ventilation SystemBreathe Technologies / cleared 2017-08-11

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)