Medical Device Recall Notification AFFECTED DEVICE

Medical Device Recalls: What Happens When a Device is Defective?

Manufacturers and distributors of medical devices are responsible for protecting public health and safety. When products fail to meet the ...

A Case Study on Device Recalls by USFDA

The study emphasized various reasons for the medical devices recalled during the year 2020. It warns the companies and users to follow the conditions strictly ...

How Philips' significant respiratory devices recall unfolded

There are 5.5 million recalled CPAPs and more. Here's a Philips recall timeline — pulled from MassDevice archives.

Appendix C: 510(k) Premarket Notification Analysis of FDA Recall ...

Read chapter Appendix C: 510(k) Premarket Notification Analysis of FDA Recall Data: The Food and Drug Administration (FDA) is responsible for ensuring tha.

Recall of Device Recall Customed

What is this? A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical ...

New requirements in Canada relating to drug and medical device ...

These amendments will introduce new reporting obligations for both voluntary (company-initiated) and mandatory recalls ordered by Health Canada for drugs and ...

Important Notice: Philips Issues Medical Device Recall

Philips Respironics recently announced a voluntary recall of certain Bi-Level PAP, CPAP, and mechanical ventilator devices, due to problems ...

URGENT: Medical Device Recall Notification - HPRA

Globus Medical has initiated a recall of all lots of ExcelsiusGPS® Cannula A, 9mm x. 250mm. This recall is being conducted because these devices ...

Ensuring Patient Safety: Medical Device Recall Process and ...

A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA).

What to Do if Your Cardiac Device Is Recalled - Columbia Doctors

A cardiac device—such as an implantable cardioverter defibrillator (ICD), a pacemaker, or the leads that connect them—helps your heart beat steadily. If a ...

TGA Notification and Recall for Medical Devices Policy

The Therapeutic Goods Administration (TGA) is a division of the Australian. Government Department of Health and is responsible for regulating ...

Class I (highest severity) recalls imply a reasonable likelihood of serious adverse events or death associated with device use. Recalled devices must be ...

FDA Announces Recall of Certain Sleep and Respiratory Devices

The Food and Drug Administration (FDA) has directed Philips Respironics to recall millions of sleep and respiratory devices following ...

Health Canada Guidance on Medical Device Recalls - RegDesk

The new article highlights the aspects related to cybersecurity for software-based medical devices intended to be marketed and used in the ...

Medical Device Recall Notification - Philips Respironics Sleep and ...

On June 14, 2021, Philips issued a recall notification for the United States for specific affected ventilation and sleep apnea devices.

Philips Recall | Romo Medical Equipment

Philips Respironics announced a voluntary recall for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices)

Medical Device Recall

Recall action has been set out in Section 42 of Act 737. Recall may be undertaken voluntarily and at any time by manufacturers and establishments, or at the ...

URGENT: MEDICAL DEVICE RECALL

Applied Medical is conducting a voluntary recall of specific lot numbers of the Epix latis Grasper due to the potential for.

Medical Device Recalls Linked to Faulty Manufacturing

A new report claims that manufacturing defects are now the number one reason for product recalls in the United States.

FDA Medical Device Recall Guidance [Process Explained]

This article clarifies guidance for FDA device recalls, defining key terms, outlining regulatory requirements for voluntary and mandatory ...