The U.S. Food and Drug Administration (FDA) has recalled the Philips’ BrightView Imaging Systems, used for single-photon emission computed tomography (SPECT) scans.
The FDA classified the recall as the most serious due to the potential risk of a detector unexpectedly falling on patients during scans.
The health regulator clarified that the recall aims to address a faulty component rather than removing the product entirely.
The issue
- The identified issue, where a detector may fall, poses risks such as neck injury, contusion, and traumatic brain injury.
- While there has been one incident related to the device’s use, the FDA reported no injuries or fatalities resulting from the incident.
- In response to the concern, Philips issued a letter to all affected customers in December, advising them not to position a patient’s lower limbs directly under the detector.
- The affected devices were manufactured and distributed between September 2007 and June 2013.
Philips is actively engaging with its customers, scheduling inspections of the systems, implementing additional safety mechanisms, and undertaking repairs as necessary.
The company emphasized that customers can continue using their systems by following the provided safety instructions.
Philips is addressing over 550 affected devices as part of the corrective measures. Despite discontinuing the production and sale of the BrightView product in 2014, Philips assured that the financial impact of the recall was negligible.
This recall adds to a series of corrective actions taken by the Dutch health technology company in recent years, including recalls of its ventilators.
Last month, Philips reached a compliance agreement with the FDA concerning its ventilator recalls.
