Reported Aug 31, 2022 · Ongoing
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and…
Getinge USA Sales Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Getinge Usa Sales Inc · 1 Geoffrey Way · Wayne, NJ · 07470-2035
Is this the product you have?
- Servo-air Ventilator System-The
- Servo-air Ventilator System isIntended for respiratory support, monitoring and treatment of pediatric and adult patients
- Model Number6882000 (equipped with 6881999 mobile cart)
- Lot codes and dates
- UDI-DI07325710003114
- Serial Numbers
155 of 155 codes
105581234920122201352014821704231772316923430236522374923762105611235020123201362015021705231782317123431236532375023763105671235120124201372015121706231792318823432236542375123857105691235220125201382015321707231802337523429236552375223858105731235320126201392015522206231832337623536236562375323973
- Amount recalled
- US 102 units; OUS 13750 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- IL
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Getinge USA Sales Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.