Draeger Medical recalls
11 official recalls and safety alerts involving Draeger Medical since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Draeger Medical or the relevant agency.
- 2024-12-25
USDraeger Medical, Inc. recalls Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in…
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA · DeviceDraeger Medical, Inc.No Atlan A300 or A300XL devices were imported into the US. Devices were direct…Official notice →- 2024-11-20
- US
Draeger Medical, Inc. recalls Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA · DeviceDraeger Medical, Inc.US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY,…Official notice → - 2024-04-24
- US
Draeger Medical, Inc. recalls Dr¿ger Perseus A500 Anesthesia Workstation
Unexpected shutdown while operating on battery power.
FDA · DeviceDraeger Medical, Inc.Domestic: Nationwide Distribution; Foreign: Angola, Argentina, Australia,…Official notice → - 2023-08-30
- US
Draeger Medical, Inc. recalls Carina Sub-Acute Care Ventilator
Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
- 2023-07-19
- US
Draeger Medical, Inc. recalls Oxylog 3000 Plus emergency and transport ventilator
Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
FDA · DeviceDraeger Medical, Inc.Distributed Nationwide. OUS Distribution: Afghanistan, Algeria, Andorra,…Official notice → - 2023-05-24
- US
Draeger Medical, Inc. recalls VentStar Basic (P)180, MP00351
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 2023-03-01
- US
Draeger Medical, Inc. recalls NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
- 2022-06-22
- US
Draeger Medical, Inc. recalls Drager SafeStar 55, Catalog No. MP01790
Possible occlusion of filters due to manufacturing error.
FDA · DeviceDraeger Medical, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - 2022-04-13
- US
Draeger Medical, Inc. recalls Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog…
Cybersecurity Improvement Action-not equipped against potential cyber security threats
- 2022-01-26
- US
Draeger Medical, Inc. recalls Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas…
FDA · DeviceDraeger Medical, Inc.US Nationwide distribution in the states of NY, PA, and WI.Official notice → - 2021-10-20
- US
Draeger Medical, Inc. recalls Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up…
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds