Another recall: does Philips have a quality control problem?

Philips’ high-profile device recalls have raised questions about its quality control. Credit: Sem van der Wal/ANP/AFP

Multinational electronics and medical device manufacturer Philips has made headlines lately for all the wrong reasons. 

The recent recall of its SPECT BrightView nuclear imaging system is the latest in a series of serious product failures that raise questions about the company’s quality control mechanisms. 

The largest of these is the FDA class I recall of a series of respirators in 2021 due to the breakdown of foams used to prevent rattling. A class I recall is the most serious type, categorised as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” 

Following the recall, the revelation by ProPublica that the company knew of the issues for years before ordering its products be pulled and the recurrence of the issue in newer models suggested that, despite its claims, the company had put profit before patient safety. 

Respironics, the subsidiary that produces Philips respirators, issued two more recalls in 2022, One for masks that used magnetic clips to secure the mask to headgear straps and another for certain ventilators with circuitry issues that could cause them to shut down without warning. The company is now facing numerous lawsuits and has agreed to halt sales of respirators in the US until problems are resolved. 

Unfortunately for Philips, respirators are not the only products it has had to recall in recent years. Whilst its SPECT BrightView system has been out of production for almost ten years, around 1,000 remain in use. A similarly limited recall happened in December 2023 when one of its MRI machines was recalled due to the risk of explosion. In 22 years of service, only one has been recorded, and no injuries have been reported. Both are class I recalls. 

In isolation, these smaller issues would not be too much cause for concern. The recalls were issued before any harm was done, and the number of these devices on the market are low. Combined with the respirator recalls, however, they are harming investor confidence.

The company’s share price is more than 50% lower than its peak in April 2021, and it has already lost 10% of its value since the start of 2024. The company is clearly aware of this, as filing mentions of its independent supervisory board skyrocketed in 2023, as did mentions of governance from 2022 to 2023.

Philips has not responded to a request for comment at time of publication, but in the past has said: “Philips’ priority is patient safety and quality.”

While Philips is one of the biggest offenders in the medical device world of late, studies suggest it is not alone. A 2023 paper published in Medical Devices: Evidence and Research examined Class I recalls in medical devices between 2018 and 2022. It found that of the 189 unique Class I recalls, 66% were for devices with multiple recalls of any class. 

In its conclusion, the paper’s authors noted: “Class I medical device recalls are common and affect millions of device units in use in the US. Completing the required actions for recall termination takes a significant amount of time, posing serious safety concerns to patients for a longer period. 

“Given the increasing frequency of recalls, the number of affected units per recall, and the widespread distribution of affected medical devices, more effort is needed to facilitate the timely and precise identification of affected devices to minimize patient harm.”