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Philips (PHG) Gains Despite Recall of SENSE XL Torso Coils
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Koninklijke Philips (PHG - Free Report) subsidiary Philips North America LLC has issued a critical recall of SENSE XL Torso (1.5T and 3.0T) coils, advising customers to adhere to updated Instructions for Use (IFU) to prevent serious injuries or death. Despite the recall, the company’s shares gained 1.8% on Image-guided therapy segment strength.
The SENSE XL Torso coils, designed for 1.5T and 3.0T MR scanners, are 16-element, receive-only coils used for imaging the torso and abdomen. Each coil includes a back part, a front part, and a connection box, and they operate independently without combining with other coils. These coils help produce diagnostic images that can be interpreted by trained physicians.
The FDA has labeled this recall as the most serious type, a Class 1 event, highlighting the potential danger these devices pose if not used correctly. The recall stems from reports of the coils heating up during MRI scans, leading to thermal injuries. All serial numbers of the specified coils are affected by this recall.
Significance of the Recall
Per Philips, this recall is of utmost importance as it directly addresses the potential risk of serious injuries, including burns, associated with the use of the SENSE XL Torso coils. Although there have been no reported deaths, there have been 12 incidents of injury, underscoring the urgency for compliance with the updated instructions. The recall ensures that users are aware of the necessary precautions to avoid further harm. By updating the use instructions, Philips aims to mitigate the risks and ensure patient safety during MRI procedures involving these coils.
Philips is grappling with several safety issues and has managed the recall of more than 15 million respiratory devices for three years or more. The company has faced several problems with its imaging machines recently.
In November, Philips recalled certain MRI scanners due to the risk of explosion, despite only one reported incident in the 22 years that the system had been in use. In February, the FDA issued a warning letter to Philips after discovering three unreported field corrections for computed tomography machines during an inspection.
Last month, Philips initiated a recall for MRI coils, affecting over 1,000 devices distributed globally. Customers were notified on May 31. The affected coils are used for developing MRI images of the torso and abdomen. The updated instructions for use advise against positioning the coils close to a machine’s bore and exceeding 45 minutes of examination time. Customers were also instructed to use the dedicated pads and mattresses supplied with the coils.
Industry Prospects
Per a report by MarketsandMarkets, the global Image-guided radiation therapy market size was worth $1.9 billion in 2023. It is anticipated to reach $2.4 billion in 2028 at a CAGR of 5.2%.
Non-invasive radiation therapy significantly mitigates the probability of surgical complications and diminishes the potential for adverse effects in the post-treatment phase. This augmentation contributes to the advancement and market elevation of image-guided radiation therapy, positioning it as a pivotal solution in the landscape of cancer treatment.
Recent Developments
In the previous month,Philips made significant advancements to bolster its Precision Diagnosis and Image-Guided Therapy portfolios, enhancing its overall Diagnosis & Treatment segment.Philips will provide technologies such as Ingenia Ambition X MR, EPIQ CVx ultrasound, AI-enabled radiology workflow solutions and patient experience technologies.
In the same month,Philips launched the Duo Venous Stent System, a medical device designed to treat chronic venous insufficiency (CVI). The stent system received premarket approval from the FDA and has been successfully implanted in a CVI patient to treat symptomatic venous outflow obstruction.
Price Performance
Shares of Philips have increased 14.5% so far this year compared with the industry's 1.9% rise. The S&P 500 has witnessed an 18.8% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Philips carries a Zacks Rank #4 (Sell).
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Philips (PHG) Gains Despite Recall of SENSE XL Torso Coils
Koninklijke Philips (PHG - Free Report) subsidiary Philips North America LLC has issued a critical recall of SENSE XL Torso (1.5T and 3.0T) coils, advising customers to adhere to updated Instructions for Use (IFU) to prevent serious injuries or death. Despite the recall, the company’s shares gained 1.8% on Image-guided therapy segment strength.
The SENSE XL Torso coils, designed for 1.5T and 3.0T MR scanners, are 16-element, receive-only coils used for imaging the torso and abdomen. Each coil includes a back part, a front part, and a connection box, and they operate independently without combining with other coils. These coils help produce diagnostic images that can be interpreted by trained physicians.
The FDA has labeled this recall as the most serious type, a Class 1 event, highlighting the potential danger these devices pose if not used correctly. The recall stems from reports of the coils heating up during MRI scans, leading to thermal injuries. All serial numbers of the specified coils are affected by this recall.
Significance of the Recall
Per Philips, this recall is of utmost importance as it directly addresses the potential risk of serious injuries, including burns, associated with the use of the SENSE XL Torso coils. Although there have been no reported deaths, there have been 12 incidents of injury, underscoring the urgency for compliance with the updated instructions. The recall ensures that users are aware of the necessary precautions to avoid further harm. By updating the use instructions, Philips aims to mitigate the risks and ensure patient safety during MRI procedures involving these coils.
Philips is grappling with several safety issues and has managed the recall of more than 15 million respiratory devices for three years or more. The company has faced several problems with its imaging machines recently.
In November, Philips recalled certain MRI scanners due to the risk of explosion, despite only one reported incident in the 22 years that the system had been in use. In February, the FDA issued a warning letter to Philips after discovering three unreported field corrections for computed tomography machines during an inspection.
Last month, Philips initiated a recall for MRI coils, affecting over 1,000 devices distributed globally. Customers were notified on May 31. The affected coils are used for developing MRI images of the torso and abdomen. The updated instructions for use advise against positioning the coils close to a machine’s bore and exceeding 45 minutes of examination time. Customers were also instructed to use the dedicated pads and mattresses supplied with the coils.
Industry Prospects
Per a report by MarketsandMarkets, the global Image-guided radiation therapy market size was worth $1.9 billion in 2023. It is anticipated to reach $2.4 billion in 2028 at a CAGR of 5.2%.
Non-invasive radiation therapy significantly mitigates the probability of surgical complications and diminishes the potential for adverse effects in the post-treatment phase. This augmentation contributes to the advancement and market elevation of image-guided radiation therapy, positioning it as a pivotal solution in the landscape of cancer treatment.
Recent Developments
In the previous month,Philips made significant advancements to bolster its Precision Diagnosis and Image-Guided Therapy portfolios, enhancing its overall Diagnosis & Treatment segment.Philips will provide technologies such as Ingenia Ambition X MR, EPIQ CVx ultrasound, AI-enabled radiology workflow solutions and patient experience technologies.
In the same month,Philips launched the Duo Venous Stent System, a medical device designed to treat chronic venous insufficiency (CVI). The stent system received premarket approval from the FDA and has been successfully implanted in a CVI patient to treat symptomatic venous outflow obstruction.
Price Performance
Shares of Philips have increased 14.5% so far this year compared with the industry's 1.9% rise. The S&P 500 has witnessed an 18.8% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Philips carries a Zacks Rank #4 (Sell).
Some top-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Universal Health Services (UHS - Free Report) and Dexcom (DXCM - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
DaVita has an estimated long-term growth rate of 13.6%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 29.4%.
DaVita’s shares have gained 34.2% compared with the industry’s 4.5% rise so far this year.
Universal Health Services has an estimated long-term growth rate of 14.80%. UHS’ earnings surpassed estimates in each of the trailing four quarters, with the average being 8.12%.
Universal Health Services has gained 20.4% compared with the industry's 17.5% so far this year.
DexCom has an estimated long-term growth rate of 22.9%. DXCM’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 34.10%.
DexCom’s shares have declined 9.4% against the industry's 3.5% increase so far this year.