Philips BrightView Imaging System Hit with Class I Recall

Philips is once again in the crosshairs of a Class I recall, this time pertaining to its BrightView Imaging system, including the BrightView X and BrightView XCT.

The BrightView system is a single photon emission computed tomography (SPECT) machine used to take images for medical review showing biological activity in the human body. The BrightView XCT model combines SPECT and CT imaging.

On Dec. 16, 2023, Philips sent out an Urgent Medical Device Correction Letter requesting users to not position a patient’s lower limbs directly under the machine’s detector as it’s support component may unexpectedly fail, fall, and not be able to move to complete the imaging.

The letter described two possible scenarios, one with the detector positioned below the center of the gantry and one above the center of the gantry.

In scenario one, Philips wrote “If the patient’s lower limb(s) is directly below the lower detector and the support component fails, the detector may descend downward in an uncontrolled manner and contact the patient.”

In the second scenario, Philips wrote, “If the support component fails, the detector will remain in place, and will not move as intended for clinical imaging, resulting in an interruption to normal system operation. A rescan or re-injection of radiopharmaceutical to the patient may be required.”

Now considered a class I recall, Philips said that if the detector fails, it may fall and cause the patient aa neck injury, contusion, traumatic brain injury/concussion, death, crush injury, fracture, laceration, muscle or ligament sprain/strain.

Effected devices were manufactured between September 2007 and June 2013, and distributed between Nov. 29, 2007, and June 5, 2013. Currently, there has been one reported incident from use of the device and no reports of injuries or deaths.

Of note, the recall is considered a correction, not a product removal. Philips wrote in the notification that it will contact customers to schedule a time for a company field service engineer to visit the customer site and correct the system if necessary.

"The BrightView systems may continue to be used in accordance with their instructions for use and the instructions in the field safety notice," said Steve Klink, head of global external relations, in a statement provided to MD+DI. "Philips is contacting customers to schedule an inspection of the system, implementation of an additional safety mechanism, and if necessary, replacement of the leadscrew. Philips stopped producing and selling the BrightView product family in 2014, and the field safety notice encompasses the remaining approx. 1,000 systems in use."