Recall archive
30 recalls · page 1 of 2
Reported Dec 25, 2024
Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand — The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand — The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Dr¿ger Perseus A500 Anesthesia Workstation
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand — Unexpected shutdown while operating on battery power.
FDA (openFDA device enforcement)
Reported Aug 30, 2023
Carina Sub-Acute Care Ventilator
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand — Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use…
FDA (openFDA device enforcement)
Reported Jul 19, 2023
Oxylog 3000 Plus emergency and transport ventilator
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand · Reason for recall — Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
FDA (openFDA device enforcement)
Reported May 24, 2023
Seattle PAP Plus, MP02260
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand — Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
21 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 1, 2023
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand · Reason for recall — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 22, 2022
Drager SafeStar 55, Catalog No. MP01790
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand · Product · Product details — Possible occlusion of filters due to manufacturing error.
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
Matched: Brand — Cybersecurity Improvement Action-not equipped against potential cyber security threats
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 26, 2022
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
Matched: Brand · Product · Product details — 26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If…
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
Matched: Brand — Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
Matched: Brand · Product details — Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 17, 2021
VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
Matched: Brand · Product · Product details — Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 30, 2019
VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand — Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 27, 2018
Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
Matched: Brand · Product details · Reason for recall — The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 6, 2018
Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
Matched: Brand · Product details — The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming…
FDA (openFDA device enforcement)
Reported May 16, 2018
Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand · Product details — The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 10, 2016
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand — Isolated episodes of leakage at the check valve were found
FDA (openFDA device enforcement)
Reported Aug 3, 2016
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
Matched: Brand — Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
FDA (openFDA device enforcement)
Reported Jun 1, 2016
Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
Matched: Brand · Product · Product details — Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can…
FDA (openFDA device enforcement)
Reported Mar 2, 2016
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand — The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and…
FDA (openFDA device enforcement)
Reported Feb 10, 2016
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand · Reason for recall — Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 30, 2015
Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand — The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care…
FDA (openFDA device enforcement)
Reported Dec 23, 2015
Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand — There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously…
FDA (openFDA device enforcement)
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