Getinge Usa Sales Inc 2022-08-31 Health serious FDA
Health · FDA · Recall #FDA-Z-1568-2022
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory… Recall
Issued August 31, 2022 · Getinge Usa Sales Inc
In August 2022, Getinge Usa Sales Inc recalled the Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk
What you should do
- 1 Stop using Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Getinge Usa Sales Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Getinge Usa Sales Inc
- Category
- Health
- Recall date
- August 31, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Australia (AU), Brazil (BR), China (CN), Egypt (EG), EEA, Hong Kong (HK), Israel
- Recall number
- FDA-Z-1568-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Getinge Usa Sales Inc has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.