Monday, July 15, 2024

Harm Risk Prompts Philips to Recall SENSE XL Torso MR Coil Due to Potential Overheating

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Harm to patients from potential overheating has prompted Philips North America LLC to initiate a Class 1 device recall for its SENSE XL Torso Coil 1.5T Mk2. The recall, identified under number Z-2165-2024, was initiated on June 5, 2024, and made public on June 27, 2024.

The SENSE XL Torso Coil, a 16-element receive-only coil used for torso and abdomen imaging in Philips MR Intera and Achieva Systems, has been flagged for its potential to heat up, posing a burn risk to patients. The recall impacts models with serial numbers including 190, 187, 71, 60, 39, 24, 244, 36, 184, 151, 185, 245, 179, and 29.

The Cambridge, Massachusetts-based company identified the device design as the root cause of the issue. In response, Philips has issued an URGENT MEDICAL DEVICE RECALL notice to consignees, dated May 31, 2024. This notice includes specific operational instructions to mitigate the risk, such as avoiding the First Level Operating Mode/High Specific Absorption Rate (SAR) scans, using dedicated pads and mattresses provided with the coils, maintaining a distance of at least two inches (5 cm) from the bore, and limiting examination time to no more than 45 minutes. Additionally, an advisory notice summarizing these recommended actions was included with the recall notification and should be displayed with affected systems to ensure access by operators.

Philips is actively developing field corrections to address the issue, which may include software risk control measures to limit scan settings, hardware updates, and design improvements for the coil. The company plans to update consignees on these actions by the end of 2024.

The recall affects 14 units distributed worldwide, including in the United States and numerous other countries such as Afghanistan, Argentina, Australia, and many more.

Philips North America LLC has initiated a Class 1 device recall for its SENSE XL Torso Coil 1.5T Mk2 due to a risk of overheating, which could potentially harm patients. This recall, identified as number Z-2165-2024, was initiated on June 5, 2024, and made public on June 27, 2024. The recall specifically impacts models with serial numbers 190, 187, 71, 60, 39, 24, 244, 36, 184, 151, 185, 245, 179, and 29. The SENSE XL Torso Coil is a 16-element receive-only coil used for torso and abdomen imaging in Philips MR Intera and Achieva Systems.

harm

Philips Issues Urgent Recall to Prevent Harm from Overheating in SENSE XL Torso Coil

The Cambridge, Massachusetts-based company pinpointed the device design as the root cause of the overheating issue. To address this, Philips issued an URGENT MEDICAL DEVICE RECALL notice to consignees on May 31, 2024. This notice includes detailed operational instructions to mitigate the risk of overheating, such as avoiding First Level Operating Mode/High Specific Absorption Rate (SAR) scans, using dedicated pads and mattresses provided with the coils, maintaining a distance of at least two inches (5 cm) from the bore, and limiting examination time to no more than 45 minutes. An advisory notice summarizing these recommended actions was included with the recall notification and is intended to be displayed with affected systems to ensure that operators can access it.

In addition to these immediate actions, Philips is working on long-term field corrections to resolve the issue. These corrections may involve implementing software risk control measures to limit scan settings, updating hardware, and making design improvements to the coil. Philips plans to update consignees on these corrective actions by the end of 2024.

This recall affects a total of 14 units that have been distributed worldwide. The affected units are not only in the United States but also in numerous other countries, including Afghanistan, Argentina, and Australia, among others. The global distribution of these units highlights the widespread impact of the recall and the importance of addressing the overheating issue promptly.

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This recall underscores the critical need for continuous monitoring and improvement of medical device safety. Overheating in medical devices, particularly those used in imaging procedures, can pose significant risks to patients, including burns. Therefore, the identification and recall of devices with such potential hazards are essential steps to ensure patient safety.

Philips’ proactive approach in issuing the recall and providing detailed instructions for mitigating the risk is commendable. By outlining specific operational guidelines and committing to long-term solutions, Philips aims to minimize the risk of harm to patients and maintain the safety and efficacy of its medical imaging products.

As the company works towards implementing these corrective measures, it is crucial for healthcare providers using the affected devices to adhere strictly to the provided guidelines. This adherence will help mitigate the immediate risks associated with the overheating issue while Philips develops and deploys permanent solutions.

In conclusion, the recall of the SENSE XL Torso Coil 1.5T Mk2 by Philips North America LLC due to the potential for overheating and subsequent harm to patients is a significant action aimed at safeguarding patient health. The company’s issuance of an urgent recall notice, along with detailed mitigation instructions and plans for long-term corrective measures, reflects a robust response to a serious safety concern. The global impact of this recall emphasizes the importance of vigilance and prompt action in the medical device industry to ensure patient safety and device reliability.

 

Resource: Food and Drug Administration, July 27, 2024

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