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Showing 1181–1200 of 8393 results

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MR 7700 Upgrade (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Ingenia Elition S (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

BD Texium Closed Male Luer (Unknown) – Leakage Risk (2025)

Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

High

FDAMay 12, 2025Nationwide

Alaris Pump Infusion Set (Unknown) – Leakage Risk (2025)

Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

FDAMay 12, 2025Nationwide

Dexcom G6 Glucose Receiver (Dexcom) – Speaker Alert Issue (2025)

Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.

FDAMay 12, 2025Nationwide• Dexcom, Inc.

Ivenix Infusion System Set (Fresenius Kabi) – Filter Positioning (2025)

Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.

FDAMay 12, 2025CA, CO, DE +15 more• Fresenius Kabi USA, LLC

BD Texium Syringe (Unknown) – Leakage Risk (2025)

Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

FDAMay 12, 2025Nationwide

Dexcom G7 Glucose Receiver (Dexcom) – Speaker Alert Issue (2025)

Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.

FDAMay 12, 2025Nationwide• Dexcom, Inc.

Dexcom One+ Glucose Monitor (Dexcom) – Speaker Alert Issue (2025)

Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.

FDAMay 12, 2025Nationwide• Dexcom, Inc.

HemoCue Glucose Microcuvettes (HemoCue) – Stability Concern (2025)

Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.

FDAMay 12, 2025Nationwide• HemoCue AB Kuvettgatan 1 Angelholm Sweden

BD Texium Needle-Free Syringe (Unknown) – Leakage Risk (2025)

Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

FDAMay 12, 2025Nationwide

Baxter Novum IQ Syringe Pump (Baxter) – Syringe Detection Issue (2025)

Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.

FDAMay 12, 2025Nationwide• Baxter Healthcare Corporation

BiPAP A40 Ventilator (Philips) – Usage Limitation (2025)

This device does not indicate for use in patients with respiratory failure.

FDAMay 9, 2025Nationwide• Philips Respironics, Inc.

BiPAP V30 Ventilator (Philips) – Usage Limitation (2025)

This device does not indicate for use in patients with respiratory failure.

FDAMay 9, 2025Nationwide• Philips Respironics, Inc.

MNA-420 Encoder (Barco) – MAC Address Conflict (2025)

Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video and/or control signals might be interrupted or fall away, displays might switch to failover and back multiple times, devices/sources/sinks might not be discovered/available, might lead to delayed/prolonged procedures

FDAMay 9, 2025Nationwide• Barco N.V. President Kennedypark 35 Kortrijk Belgium

Welch Allyn Battery (Baxter) – Short Circuit Risk (2025)

The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.

FDAMay 9, 2025Nationwide• Baxter Healthcare Corporation

VITROS 5600 System (Ortho-Clinical) – Test Result Error (2025)

A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

FDAMay 9, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

BiPAP A30 Ventilators (Philips) – Usage Limitation (2025)

This device does not indicate for use in patients with respiratory failure.

FDAMay 9, 2025Nationwide• Philips Respironics, Inc.

Optima Coil System (Balt USA) – Radiopaque Marker Issue (2025)

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

FDAMay 8, 2025Nationwide• BALT USA, LLC

Zen-O Lite Oxygen Concentrator (Ohio Medical) – Calibration Error (2025)

Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.

FDAMay 8, 2025Nationwide• Ohio Medical Corporation

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