Category: Recalls

Recalls

LivaNova Recalls Blood Pump Device for Risk of Unintentional Extended Pump Stop

LivaNova is recalling the LifeSPARC Controller due to a software update being available to address a previous software malfunction.

Recalls

Baxter Hillrom Recalls Incontinence Management System Due to RF Interferences

Baxter Hillrom is recalling its incontinence management system following reports that its radio frequency emissions interferes with devices.

Recalls

Malfunctioning Integra Intracranial Monitor Was Used on Patient Who Died: FDA

The U.S. FDA has identified one patient death that was tied to the use of Integra LifeSciences CereLink ICP monitors.

Recalls

LivaNova Recalls Blood Pump Device for Risk of Unintentional Extended Pump Stop

LivaNova is recalling the LifeSPARC Controller due to a software update being available to address a previous software malfunction.

Philips Recall Sparks 48K Complaints to FDA in Three Months, Including 44 Deaths

Aug 18, 2022

The FDA updated a safety communication regarding the ongoing recall issues of Philips’ respiratory devices.

Royal Philips Names New CEO Amid Recall Woes

Aug 17, 2022

Roy Jakobs is tapped to succeed Frans van Houten as Royal Philips’ president and CEO, effective October 15. Jakobs has been critical in helping Philips address ongoing medical device recall challenges, the company says.

Smiths Medical Issues Device Correction Related to Fast-Flow Fluid Warmers

Aug 5, 2022

Smiths Medical had notified customers of a potential issue with specific Level 1 H-2 Pressure Chambers used with Level 1 Fast Flow Fluid Warmers.

SxanPro & NotiSphere Partner to Help Manage Product Recalls

Jul 27, 2022

SxanPro and NotiSphere partnered to leverage their combined technologies to identify and manage recalled products in a master inventory list.

Philips Could Be Approaching a DOJ Settlement

Jul 26, 2022

Philips may be looking to bring an end to its ongoing plight of medical device recalls via a settlement agreement with the DOJ.

Smiths Medical Recalls Certain Syringe Infusion Pumps for Software Issues

Jul 20, 2022

Smiths Medical is recalling infusion pumps for eight software malfunctions that affect different serial numbers and software versions.

Recalls

Unpacking Averages: Common Root Causes Driving Medical Device Recalls

The National Law Review published data aimed at providing insight for companies regarding product recalls.