Searching in Pharma & Drug Safety · Search everything
104 changes Priority review, last 7 days
Philips Respironics BiPAP A40 Pro Ventilator - Discontinuation and Safety Alert
Philips Respironics is discontinuing the BiPAP A40 Pro ventilator globally due to an internal oxygen sensor defect causing false alarms. The company offers patients options for continued care, including device replacement or partial reimbursement. Healthcare providers must inform affected patients of these options.
Curosurf 240 mg/3 ml Suspension Recall by Chiesi SAS
The French ANSM has announced a recall of a specific lot (Lot 1211845, Exp 07/2026) of Curosurf 240 mg/3 ml suspension for endotracheobronchial instillation. This action was initiated by the manufacturer, Chiesi SAS, as a precautionary measure due to a resolved deviation observed during environmental monitoring.
Philips Spectral CT Scanner Software Safety Alert
The French ANSM has issued a safety alert (R2607608) regarding Philips Spectral CT scanner systems with software version 5.1.X. Healthcare facilities using these devices have been notified of a security action initiated by Philips Medical Systems BV.
Leksell Vantage stereotactic system safety information
The French ANSM has issued a safety notice regarding the Leksell Vantage stereotactic system by Elekta Ltd. This action, registered under number R2607991, is based on a safety action implemented by the manufacturer. Affected healthcare facilities have been notified.
ANSM Drug & Device Safety Alert: Endoscopic Clip Device
The French ANSM has issued a safety information notice regarding a recall of specific lots of the Instinct Plus endoscopic clip device by Wilson-Cook Medical, Inc. This action follows a previous safety alert and is registered under ANSM reference R2606331.
ANSM Safety Recall: Autoimmunity IDS SS-A/Ro Reagent
The French ANSM has issued a safety recall (R2532493) for a specific lot of the Autoimmunity IDS SS-A/Ro reagent manufactured by Immunodiagnostic Systems (IDS). Laboratories using this reagent have been notified directly by the manufacturer.
ANSM Safety Information for Hemostasis Reagent STA NeoPTimal 5
The French ANSM has issued a safety information notice regarding the Hemostasis Reagent STA NeoPTimal 5, manufactured by Diagnostica Stago. Affected users have been notified directly by the company, and the action is registered under ANSM number R2607353.
FDA: Dialysis Tubing Sets Recalled Due to Dislodging, Updated Instructions
The FDA is alerting healthcare providers about a recall of Vantive dialysis tubing sets due to potential dislodging of the deaeration chamber. Updated instructions for use have been issued to mitigate risks, emphasizing monitoring the chamber during therapy. This is a correction and does not involve removing the devices from use or sale.
DEA Seattle Fentanyl Enforcement and Awareness Initiative
The DEA's Seattle Division is launching a "Fentanyl-Free America" initiative in the Pacific Northwest, focusing on increased enforcement, education, and awareness. This initiative aims to combat the fentanyl crisis through collaborative efforts.
Neonatal incubator safety alert: Lifetherm 2000
The ANSM has issued a safety alert regarding the Lifetherm 2000 neonatal incubator manufactured by Löwenstein Medical GmbH & Co. KG. The alert, registered under number R2607231, concerns a specific healthcare facility and includes a letter from the manufacturer detailing the safety action.
Get alerts for ""
We'll email you when new changes match this search.
Free. Unsubscribe anytime.