Philips controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2021
Philips Respironics device recall
Philips recalled numerous sleep and respiratory-care devices after concerns involving the degradation of sound-abatement foam and possible exposure to particles or chemicals. The recall generated regulatory scrutiny, product remediation requirements, litigation and significant operational disruption.
2021
Respironics California recalls V60 ventilators
Recall announced
Respironics California, Inc. initiated a Class II recall of V60 ventilators after Philips identified problems with backup batteries in certain models and batches. The affected products were not sold in China. The recall was reported on April 19, 2021.
Source excerpt
由于涉及特定型号、特定批次产品备用电池存在问题，生产商Respironics California，Inc.对呼吸机（注册证号：国械注进20163545139）主动召回。召回级别为二级。
本次涉及地区和国家为美国
2021
Philips announces repairs and replacements for recalled sleep apnea devices
Corrective action
In 2021, Philips announced that it would begin repairing recalled sleep apnea devices in September and had already started replacing certain first-generation DreamStation CPAP devices. The devices were recalled because the foam used in them posed health risks. The announcement addressed the repair and replacement of affected devices following the recall.
Company response
Remediation — Philips
The company announced that it will begin repairing devices this month and has already started replacing certain first-generation DreamStation CPAP devices with a newer version of the product.
Source excerpt
The company announced that it will begin repairing devices this month and has already started replacing certain first-generation DreamStation CPAP devices with a newer version of the product.
The Food and Drug Administration (FDA) has authorized Philips to start repairing the first-generation DreamStation sleep apnea machines that were recalled in June because foam used in the devices posed health issues to consumers.
2021
Philips recalls sleep and respiratory care devices
Recall announced
In June 2021, Royal Philips recalled certain sleep and respiratory care devices in the United States due to potential health risks associated with PE-PUR sound-abatement foam. The company also announced updated instructions for use and a repair and replacement program for affected devices. The recall concerned specific devices and was accompanied by these measures to address the foam-related concerns.
Stated objective. To inform patients and customers of potential impacts on health and clinical use, and provide instructions on actions to be taken.
Company response
Remediation — Philips
The company announced corrective actions including the deployment of updated instructions for use and a repair and replacement program for affected devices.
Source excerpt
The company announced corrective actions including the deployment of updated instructions for use and a repair and replacement program for affected devices.
Royal Philips has recalled specific sleep and respiratory care devices due to the potential health risks related to the polyester-based polyurethane or PE-PUR sound abatement foam component.
The recall was issued only to the Unites States customers in consultation with regulatory agencies to mitigate the risks related to the PE-PUR sound abatement foam component in these devices.
2021
Philips recalls ultrasound systems affected by software defect
Recall announced
Philips Ultrasound, Inc. initiated a Class II recall of specified Diagnostic Ultrasound System and Transducer products. According to the report, a software defect could cause EPIQ and EPIQ AFFINITI systems to freeze while reviewing or adjusting xPlane examination results, obstructing continued clinical use. The report stated that no units had been sold in China.
Company response
Recall — Philips Ultrasound, Inc.
生产商飞利浦超声股份有限公司Philips Ultrasound, Inc.对彩色超声诊断系统Diagnostic Ultrasound System and Transducers（注册证号：国械注进20193062262、国械注进20183230036、国械注进20213060175、国械注进20193061914、国械注进20193061919、国械注进20203060422、国械注进20153231350、国械注进20153061349）主动召回。召回级别为二级。
Source excerpt
国家药品监督管理局网站近日发布了飞利浦超声股份有限公司Philips Ultrasound, Inc.对彩色超声诊断系统Diagnostic Ultrasound System and Transducers主动召回得公告。
日前，飞利浦（中国）投资有限公司报告，由于涉及特定型号、特定批次产品，存在由于软件缺陷，在审阅或调整xPlane检查结果时，EPIQ和EPIQAFFINITI超声系统可能没有响应（锁定），阻碍用户继续进行临床使用的问题
2021
SoClean sues Philips over statements about ozone cleaners
Lawsuit filed
SoClean filed a $200 million lawsuit against Philips, alleging that Philips falsely linked problems with recalled sleep apnea machines to cleaning methods used in SoClean products. These are allegations in the complaint, not a court determination.
Source excerpt
SoClean, a Peterborough-based manufacturer of ozone-based sleep apnea machine cleaners, has filed a $200 million lawsuit against the Dutch medical equipment giant Philips, saying the company falsely linked problems with its recalled sleep apnea machines to the cleaning methods used in SoClean products.
SoClean said in a lawsuit filed Oct. 12 in Boston federal court that Philips is “pointing the finger at SoClean’s ozone cleaners to divert attention away from Philips’ poor choice of materials and obvious design flaws” in its CPAP devices, which the company recalled in June over potential problems with the foam used to muffle the machines’ noise.
2020
Philips recalls Avent video baby monitors over battery overheating risk
Recall announced
Philips announced a recall of 2,142 Philips Avent digital video baby monitors produced from January 2016 to March 2018. The monitor's parent unit battery could overheat while powered, creating a fire risk. Philips said it would provide returns and refunds and cover related recall costs.
Stated objective. 消除安全隐患
Company response
Refund or compensation — 飞利浦
飞利浦还表示，将以退货返款形式整机进行召回，并且承担此次召回产品可能产生的所有费用，以消除安全隐患。
Source excerpt
飞利浦还表示，将以退货返款形式整机进行召回，并且承担此次召回产品可能产生的所有费用，以消除安全隐患。
而标称时间2020年1月8日的信息显示，飞利浦（中国）投资有限公司按照《消费品召回管理暂行规定》的要求，主动向上海市市场监督管理局报告了召回计划，将自即日起，召回2016年1月至2018年3月期间生产的部分飞利浦新安怡数字视频婴儿监视器，涉及数量为2142件。召回原因是：这款产品的父母端装置（显示器）在通电时，锂电池可能会出现过热现象，存在起燃的安全隐患。