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.
FDA Recall Z-0484-2021 · Posted None
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Recalling FirmHill-Rom Manufacturing, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2020-11-12
Date Terminated2022-11-10
Product Quantity67 devices
Reason for Recall
Under certain conditions, there is a risk for fire.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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