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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 - 4 of 4 items.

" " 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
" " Fabian HFOi Ventilator
Bias flow selection for NO system usage is missing from the user interface of Fabian HFOi Ventilators following incorrect selection of device configuration during a software update. This is caused by human error and there is no defect in the device or…
RecallHealth product recall | 2022-04-12
" " Bellavista Ventilator
Ventilation stops during clinical use, with waveforms and parameters frozen (not updated). a continuous audible/visual high priority alarm for technical failure 305 is generated. ventilation is suspended until unit is rebooted/replaced. Recall start…
RecallHealth product recall | 2021-12-31
" " Puritan Bennett 980 Series Ventilator
This voluntary medical device correction is being taken following the investigation of six customer reports stating that a total of four ventilators became inoperable during use. One of these reports indicated that, following the ventilator becoming…
RecallHealth product recall | 2021-11-29
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