Recall Z-0484-2021— Hill-Rom Manufacturing, Inc.

Name: FDA recall Z-0484-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-12

Class II · Terminated

Class II FDA medical device recall by Hill-Rom Manufacturing, Inc., initiated 2020-11-12, terminated 2022-11-10. It names one FDA 510(k) clearance: K170037. 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.. Reason: Under certain conditions, there is a risk for fire..

Recalling firm: Hill-Rom Manufacturing, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-11-12
Terminated: 2022-11-10
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K170037 — Breathe Technologies Life2000 Ventilation SystemBreathe Technologies·cleared 2017-08-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Under certain conditions, there is a risk for fire.

Data sourced from openFDA. This site is unofficial and independent of the FDA.