Search
Type
Audience
Category
Issue
Last updated
Recall class
Please note: using the search filters may not provide accurate search results for records prior to November 2021. When searching for older records, please ensure that you use the include archived checkbox.
Displaying 1 - 11 of 11 items.
Filter/HME Twinstar Plus
Manufacturer's market surveillance activities revealed cases of increased inspiratory resistance resulting in insufficient ventilation, which may be related to formation of condensate in the filter housing.
Device is intended exclusively for…
RecallHealth product recall | 2023-08-04
Carina Ventilators
The recall is being initiated as there is a potential contamination of breathing gas. During standard tests, concentrations of 1,3-dichloropropan-2-ol were measured that exceed the acceptable uptake level during continuous use (>30 days in…
RecallHealth product recall | 2023-07-13
Oxylog 3000 Plus - Basic Unit
During the course of global market surveillance activities, the manufacturer has become aware of cases where Oxylog 3000 Plus emergency and transport ventilators have stopped ventilation due to empty batteries despite being reconnected to the mains power…
RecallHealth product recall | 2023-05-31
Ventstar Breathing Circuits
During global market surveillance activities, manufacturer became aware of cases in which glued connections of the breathing circuits became loose either before or during the ventilation process resulting in partial or complete detachment of…
RecallHealth product recall | 2023-04-04
Anesthesia Set Flex, Latex Free, Us
In the course of internal quality controls, Draeger has noticed that some of their flex ventilation hoses have contaminations. Due to a deviation in the manufacturing process, components of the hose material remained as particles inside the hoses.…
RecallHealth product recall | 2023-02-08
Novastar Full Face Mask
In case the magnets of the Novastar TS and Novastar Plus are positioned near medical devices (implanted as well as not-implanted) and metallic implants the magnetic field might impact the implants or devices and cause serious injury.
Recall start date…
RecallHealth product recall | 2023-01-24
Pulmovista 500 System
The affected products with SW version 1.3 and lower may have potential cybersecurity vulnerabilities with unauthorized physical access to the USB data interfaces of the device.
Recall start date: June 7, 2022
RecallHealth product recall | 2022-08-02
Primus Anaesthetic Workstation
During global post market surveillance activities cases have been reported that the sampling pump 6873493 shows a changing characteristic with increasing operating time, which can lead to the deactivation of the gas measurement during operation. The…
RecallHealth product recall | 2022-05-10
Breathing System Filter Safestar 55
Dräger has become aware of one case in which an obstructed Breathing System Filter Safestar 55 was used on a patient during anesthesia. The patient reportedly became hypoxic and had to be reanimated. If an obstructed filter is used on a patient,…
RecallHealth product recall | 2022-05-10
Zeus Infinity Empowered (Anesthesia Workstation)
Draeger has become aware of cases in which the diva sevoflurane modules (part number:MK01703) stopped agent delivery during application of high fresh gas flow and high agent percentage.
Recall start date: Apr 6, 2022
RecallHealth product recall | 2022-04-11
Infinity Acute Care
The abovementioned ventilators use specially hardened operating system. Components of the imbedded operating systems can no longer be updated, and any potential vulnerabilities cannot be addressed. Therefore, they are not prepared against potential cyber…
RecallHealth product recall | 2022-03-14