Recall Z-0484-2021 · CBK Ventilator, Continuous, Facility Use
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.
| Date | Nov 12, 2020 |
| Status | Terminated |
| 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 le |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170037 | Breathe Technologies Life2000 Ventilation System Breathe Technologies, Aug 11, 2017 |