Tag: recall

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Defibtech Recalls Chest Compression Devices for Malfunction

Defibtech is recalling its RMU-2000 ARM XR Chest Compression Devices due to a motor issue that may cause the device to stop compressions, leading to potential patient injury or death.

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Court Restricts Philips Respironics CPAP and BiPAP Production

A consent decree of permanent injunction was issued against Philips Respironics, halting production of their sleep therapy devices.

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Senators Call for Review of ‘Ineffective’ FDA Recall Policies

Senators Durbin and Blumenthal have requested the Government Accountability Office (GAO) to review the FDA's policies on medical device recalls, citing the Philips Respironics case and a significant increase in recalls.

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Defibtech Recalls Chest Compression Devices for Malfunction

Defibtech is recalling its RMU-2000 ARM XR Chest Compression Devices due to a motor issue that may cause the device to stop compressions, leading to potential patient injury or death.

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.

Philips CPAP Recall Spurs Another 82 Reports of Patient Deaths, Pushing Total to 346

Feb 13, 2023

Recent medical device reports regarding Philips’ CPAP machines registered additional fatalities, expanding the number of reported deaths.

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.

Healthcare Workers File Petition Asking FDA to Recall Fresenius Dialysis Machines

Jan 23, 2023

A petition was submitted to the FDA to issue a corrective recall requiring modifications to dialysis machines manufactured by Fresenius.

Gaps in Recalls of Home Medical Devices Top ECRI’s Hazards List

Jan 18, 2023

ECRI has named gaps with recalls of home-use medical devices as the nation’s most pressing health technology safety issue for 2023.

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Frustrations Grow Over Company’s Response to CPAP Recalls

Philips has experienced thousands of complaints, lawsuits, criminal investigations, and a potential DOJ settlement related to CPAP recalls.