• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Getinge anesthesia systems recall is Class I

Getinge anesthesia systems recall is Class I

July 6, 2022 By Sean Whooley

Getinge Flow-e anesthesia system
The Flow-e anesthesia system [Image from Getinge]
The FDA today issued a notice confirming that Getinge’s recall of certain anesthesia systems is Class I, the most serious kind.

Getinge initiated the recall of its Flow-c and Flow-e anesthesia systems (product codes 6887700 and 6887900) due to cracked or broken suction system power switches on May 2, 2022. The systems provide inhalation anesthesia and control the ventilation of patients who have no ability to breathe and can also support the breathing of people with limited ability to do so themselves.

Affected products were distributed between June 2, 2020, and Feb. 15, 2022, according to a news release. To date, the recall has affected 64 devices in the U.S., with a total of 21 complaints, no injuries and no deaths associated with the use of the affected device, according to the notice.

The company received reports of cracked or broken on/of switches on the Flow-c and Flow-e systems’ suction unit. If the on/off switch breaks, the unit will not work to remove fluids such as phlegm, blood or stomach (gastric) content from the patient’s mouth and/or airways.

Should this issue occur, it could cause a delay during a procedure or in between procedures if the anesthesiologist needs to find another way to suction fluids. If the suction device is not working for a longer period of time, the fluids could block a patient’s breathing.

Risks associated with such a blockage may include choking, the inability of oxygen to get into the blood (acute respiratory failure), an infection in the lungs that prevents oxygen from getting to the blood, brain injury caused by lack of oxygen to the brain (hypoxia) and/or death.

Getinge told users in its medical device correction letter in May that they should examine their inventory immediately to determine if any affected Flow-c and/or Flow-e anesthesia systems are in use. They can continue use of any affected devices but should perform the recommended daily system check-out and pre-anesthesia checkout procedures, including checking the functionality of the suction unit.

If a cracked or broken on/off switch is found, customers should replace the machine with a fully functioning one or ensure that a temporary alternative suction substitute is available.

Filed Under: Featured, Food & Drug Administration (FDA), Hospital Care, News Well, Recalls, Regulatory/Compliance Tagged With: Getinge

More recent news

  • Medtronic earns CE mark for redo TAVI procedure
  • Natus Neuro launches BrainWatch AI-driven, point-of-care EEG
  • Boston Scientific has positive real-world Acurate Prime TAVI data
  • Johnson & Johnson MedTech launches ultrasound catheter for imaging in cardiac ablation procedures
  • Onward reports more successful BCI implants

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy