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Showing 861–880 of 22584 results

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X5-1 Transducer Probe (Philips) – Useful Life Clarification (2025)

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

FDAJul 3, 2025Nationwide• Philips Ultrasound, Inc

Orascoptic Superior Visualization (Orascoptic) – Nickel Allergy Risk (2025)

Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

FDAJul 3, 2025Nationwide• Orascoptic Surgical Acuity

Stryker SmartPump Tourniquet (Stryker) – Cuff Detachment Risk (2025)

Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.

Very High

FDAJul 2, 2025Nationwide• Stryker Corporation

GE OEC 9800 (GE Medical Systems) – Regulatory Non-Conformance (2025)

GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.

FDAJul 2, 2025Nationwide• GE Medical Systems, LLC

Sparrow Ascent Patient Controller (Spark Biomedical) – Cable Disconnect (2025)

Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.

FDAJul 2, 2025Nationwide• Spark Biomedical Inc

GE OEC 9900 Elite C-arm Systems (GE Medical Systems) – Non-Conformance (2025)

GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.

FDAJul 2, 2025Nationwide• GE Medical Systems, LLC

Robotic/Laparoscopy Kit (Carefree Surgical) – Sterility Compromise (2025)

Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging

FDAJul 1, 2025Nationwide• Carefree Surgical Specialties

Junctional Emergency Treatment Tool (North American Rescue) – Manufacturing Defect (2025)

Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.

FDAJul 1, 2025Nationwide• North American Rescue LLC.

Ingenia 3.0T CX (Philips) – Gradient Coil Failure (2025)

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

FDAJun 30, 2025Nationwide• Philips North America

MR 7700 (Philips) – Gradient Coil Failure (2025)

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

FDAJun 30, 2025Nationwide• Philips North America

SmartPath to dStream 3.0T (Philips) – Gradient Coil Failure (2025)

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

FDAJun 30, 2025Nationwide• Philips North America

SmartPath to Ingenia Elition X (Philips) – Gradient Coil Failure (2025)

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

FDAJun 30, 2025Nationwide• Philips North America

SmartPath dStream XR/3.0T (Philips) – Gradient Coil Failure (2025)

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

FDAJun 30, 2025Nationwide• Philips North America

DreamStation Auto CPAP (Philips Respironics) – Configuration Error (2025)

Devices may possess a programming error resulting in an incorrect device configuration.

FDAJun 30, 2025Nationwide• Philips Respironics, Inc.

HeartSine SAM Defibrillators (HeartSine) – Component Malfunction (2025)

Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)

FDAJun 30, 2025Nationwide• HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom

Laser Light Show Projectors (Beyond Laser) – Remote Interlock Issue (2025)

The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.

FDAJun 30, 2025Nationwide• Beyond Laser Systems, LLC

MR 5300 (Philips) – Gradient Coil Failure (2025)

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

FDAJun 30, 2025Nationwide• Philips North America

Evolution Upgrade 1.5T (Philips) – Gradient Coil Failure (2025)

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

FDAJun 30, 2025Nationwide• Philips North America

Intera 3.0T Quasar Dual (Philips) – Gradient Coil Failure (2025)

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

FDAJun 30, 2025Nationwide• Philips North America

Ingenia 3.0T (Philips) – Gradient Coil Failure (2025)

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

FDAJun 30, 2025Nationwide• Philips North America

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