CLASS II Device recall · Reported 2 Dec 2020 · FDA Enforcement Report

Life2000 Ventilation System recalled by Hill-Rom Manufacturing

Hill-Rom Manufacturing is recalling Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, distributed nationwide in the US. The recall was initiated on 12 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDevices 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

Quantity recalled67 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0484-2021
FDA event ID: 86756
Recalling firm: Hill-Rom Manufacturing, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 12 Nov 2020
FDA classified: 24 Nov 2020
Reported: 2 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

12 Nov 2020	Recall initiated by company
24 Nov 2020	Classified by FDA	+12 days
2 Dec 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Under certain conditions, there is a risk for fire.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arkansas Arizona California Delaware Florida Illinois Indiana Kentucky Minnesota North Carolina New Mexico Nevada New York Ohio Oklahoma Texas Utah Virginia Vermont Wisconsin

Questions about this recall

Is Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor recalled?

Yes. Hill-Rom Manufacturing recalled Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor on 12 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0484-2021.

Why was it recalled?

Under certain conditions, there is a risk for fire.

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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