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FDA Flags Recall Involving IMRIS MRI Systems Linked to Siemens 3T Magnet Issue

The recall affects IMPRIS Neuro III-SV models that use Siemens 3T magnets, citing a risk of blocked helium venting during a magnet quench.

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FDA Issues Class I Recall for Ambu Manual Resuscitators

The most serious type of recall was initiated due to a blocked manometer port, which can prevent pressure monitoring and lead to severe patient harm.

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Medical Device Recalls Reach Highest Level in Four Years

Sedgwick brand protection releases a year-in-review analysis of 2024 recall data, including the top five failures for medical devices.

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FDA Flags Recall Involving IMRIS MRI Systems Linked to Siemens 3T Magnet Issue

The recall affects IMPRIS Neuro III-SV models that use Siemens 3T magnets, citing a risk of blocked helium venting during a magnet quench.

Avanos Medical Recalls Closed Suction Systems for Young Children

Apr 21, 2023

The FDA has identified Avanos Medical’s recall of certain airway access devices for children, infants, and neonates as a Class I recall

Getinge Subsidiary’s Intra-Aortic Balloon Pumps Get Class I Recall

Mar 17, 2023

Getinge subsidiary Datascope is recalling two types of Intra-Aortic Balloon Pumps due to the possibility of unexpected device shutdown.

FDA Class I Recalls Hit 15-Year High in 2022

Mar 3, 2023

Sedgwick released its 2023 Product Recall Index, which detailed why defective and violative products reached a record-breaking high.

Reworked Philips Ventilators Get Class I Recall for Potential Foam Debris Issues

Feb 17, 2023

Philips Respironics recalled certain reworked ventilators for issues related to foam adhesion failure and foam debris.

GE HealthCare Recalls Nuclear Medicine Systems

Feb 16, 2023

GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two of its mechanisms.

Smiths Medical Infusion Pump Support Solutions Get FDA Class I Recall

Feb 6, 2023

Smiths Medical is recalling certain computerized ambulatory delivery device (CADD) administration sets and medication cassette reservoirs—both of which are intended for use with CADD infusion pumps—for two potential issues.

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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.

Tag: class 1 recall

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