Regulation Archives - NS Medical Devices

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Home » Recalls » Regulation

FDA classifies B. Braun Medical’s recall of pump system as Class 1

By NS Medical Staff Writer

20 Nov 23

The Infusomat Space Volumetric Infusion Pump System models are being recalled by the company due to defective occlusion…

RegulationRecalls

FDA classifies B. Braun Medical’s recall of pump system as Class 1

FDA classifies Abbott’s recall of Proclaim and Infinity IPGs as Class 1

FDA classifies Abbott’s recall of Proclaim and Infinity IPGs as Class 1

By NS Medical Staff Writer

14 Sep 23

The Proclaim and Infinity IPGs were recalled due to their inability to exit magnetic resonance imaging (MRI) mode…

RegulationRecalls

FDA classifies GE HealthCare’s TruSignal SpO2 sensors recall as most severe

FDA classifies GE HealthCare’s TruSignal SpO2 sensors recall as most severe

By NS Medical Staff Writer

31 Jul 23

The TruSignal sensors were recalled because of their potential to decrease the energy delivered to the heart during…

RegulationRecalls

FDA classifies Draeger’s recall of Oxylog 3000 ventilators as Class 1

FDA classifies Draeger’s recall of Oxylog 3000 ventilators as Class 1

By NS Medical Staff Writer

14 Jul 23

Germany-based Draeger Medical has recalled the Oxylog 3000 Plus Emergency and Transport Ventilators over the potential risk of…

RegulationRecalls

FDA classifies BearCare’s Walnut Wearable thermometer recall as Class 1

FDA classifies BearCare’s Walnut Wearable thermometer recall as Class 1

By NS Medical Staff Writer

16 Jun 23

According to the FDA, the possible overheating and leakage of corrosive chemicals from the device can lead to…

RecallsPatient Care DevicesPatient Care Monitoring

FDA identifies Draeger’s recall of Seattle PAP Plus and other products as Class I

FDA identifies Draeger’s recall of Seattle PAP Plus and other products as Class I

By NS Medical Staff Writer

25 May 23

Initiated by the medical equipment maker on 17 April 2023, the recall involves a total of 570,459 devices…

RegulationRecalls

FDA classifies Avanos’ recall of BALLARD ACCESS Closed Suction Systems as Class I

FDA classifies Avanos’ recall of BALLARD ACCESS Closed Suction Systems as Class I

By NS Medical Staff Writer

24 Apr 23

The US-based medical technology company is recalling its BALLARD ACCESS Closed Suction System for neonates and paediatrics distributed…

RegulationRecalls

FDA identifies recall of Philips’ DreamStation devices as Class I

FDA identifies recall of Philips’ DreamStation devices as Class I

By NS Medical Staff Writer

10 Apr 23

The Dutch medical devices maker recalled 1,088 devices in the US in February this year over the risk…

RegulationRecalls

FDA classifies LivaNova’s recall of LifeSPARC system’s controller as Class I

FDA classifies LivaNova’s recall of LifeSPARC system’s controller as Class I

By NS Medical Staff Writer

30 Jan 23

The US health regulator claimed that the device could reach critical failure mode due to a problem in…

RegulationRecalls

Tests on recalled DreamStation devices show limited risks to health, says Philips

Tests on recalled DreamStation devices show limited risks to health, says Philips

By NS Medical Staff Writer

22 Dec 22

The tests were performed to assess potential health risks with the polyester-based PE-PUR sound abatement foam in specific…

RegulationRecalls