News | SPECT Imaging | February 15, 2024

Please be aware, this recall is a correction, not a product removal.

The FDA recalls the Philips BrightView XCT

Image courtesy of Philips


February 15, 2024 — According to a release issued by the U.S. Food and Drug Administration (FDA), Philips is recalling its BrightView, BrightView X, and BrightView XCT, as the detector may unexpectedly fall due to a component failure. Update as of 12:59 pm 2/15/24 from the FDA: Please be aware, this recall is a correction, not a product removal.

Use of the affected device may cause a person to experience neck injury, contusion, traumatic brain injury/concussion, death, crush injury, fracture, laceration, muscle or ligament sprain/strain, as well as an interruption to the BrightView system operation. If detector is positioned above the large opening of the device (the center of the gantry), there may be an interruption to normal system operation.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a correction, not a product removal.

Recalled Product

  • Product Names: BrightView, BrightView X, BrightView XCT
  • Product Codes: See Recall Database Entry
  • Model Numbers:
    • BrightView: 882480; 453560279781, 453560279791, 453560279811, 453560279801, 2170-3000A, 2170-3001A, 2170-3002A, 2170-3003A
    • BrightView X: 882478; 453560824741, 453560829261
    • BrightView XCT: 882482; 453560462131, 453560749161
  • Manufacturing Dates: September 2007 to June 2013
  • Distribution Dates: November 29, 2007 to June 5, 2013
  • Devices Recalled in the U.S.: 553
  • Date Initiated by Firm: December 15, 2023

Device Use

The Philips Brightview system is a Single Photon Emission Computed Tomography (SPECT) machine used to take images showing biological activity in the human body, for medical personnel to review. The BrightView XCT model combines SPECT and Computed Tomography (CT) imaging.

Reason for Recall

Philips is recalling their BrightView, BrightView X, and BrightView XCT, as the detector may unexpectedly fall due to a component failure.

A falling detector may cause a person to experience neck injury, contusion, traumatic brain injury/concussion, death, crush injury, fracture, laceration, muscle or ligament sprain/strain, as well as an interruption to the BrightView system operation. If detector is positioned above the large opening of the device (center of the gantry), there may be an interruption to normal system operation.

There has been one reported incident from use of this device, and no reports of injuries or deaths.

Who May be Affected

  • People who receive scans using a Philips BrightView, BrightView X, BrightView XCT.
  • Health care providers who use BrightView Camera Systems to obtain detailed pictures or measurements of the human body.
  • Field service engineers who service a Philips BrightView, BrightView X, BrightView XCT.

What to Do

On December 16, 2023, Philips sent all affected customers an Urgent Medical Device Correction letter.

The letter requested all affected users to not position a patient's lower limbs directly under the detector, below the center of the gantry. If the detector is above the center of the gantry and the detector support component fails, the detector will not be able to move to complete the imaging.

The letter also described two scenarios:

  • Scenario 1: Detector positioned below the center of the gantry: 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.
  • Scenario 2: Detector above the center of the gantry: 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.

Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit the customer site and correct the system if necessary.

Contact Information

Customers in the U.S. with questions about this recall should contact the Customer Care Solutions Center at 1-800-722-9377.

Additional Resources

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.


Related Content

News | ACR

April 15, 2023 — The American College of Radiology (ACR) released an update to its ACR Appropriateness Criteria (ACR AC) ...

Time April 13, 2024
arrow
News | Magnetic Resonance Imaging (MRI)

April 10, 2024 — Online MRI and CT education leader, ImagingU, announced the launch of a new course for students and ...

Time April 10, 2024
arrow
Feature | Radiation Oncology | By Melinda Taschetta-Millane

In a new 3-part video series on advancements in diagnostic radiology with Robert L. Bard, MD, PC, DABR, FASLMS ...

Time April 10, 2024
arrow
News | Radiation Dose Management

April 9, 2024 — Mirion Dosimetry Services, a Mirion Medical company, today announced commercial availability of its ...

Time April 09, 2024
arrow
News | Ultrasound Imaging

April 9, 2024 — A new Society of Radiologists in Ultrasound (SRU) expert consensus statement to improve endometriosis ...

Time April 09, 2024
arrow
News | Magnetic Resonance Imaging (MRI)

April 8, 2024 — Magnetic resonance-guided focused ultrasound (MRgFUS) is a non-invasive technique for neuroregulation ...

Time April 08, 2024
arrow
News | Magnetic Resonance Imaging (MRI)

April 5, 2024 — Osteoarthritis — not age — may play the greatest role in determining the utility of MRI for patients 45 ...

Time April 05, 2024
arrow
News | Mammography

April 4, 2024 — Siemens Healthineers announces the Food and Drug Administration 510(k) clearance of the MAMMOMAT B ...

Time April 04, 2024
arrow
Feature | Radiology Business | By Melinda Taschetta-Millane

Here is a snapshot of the Top 10 most-read content from ITN's viewers during the month of March: 1. Philips Teams with ...

Time April 04, 2024
arrow
News | Radiology Imaging

April 3, 2024 — GE HealthCare announced the U.S. FDA 510(k) Clearance of IONIC Health’s nCommand Lite technology. The ...

Time April 03, 2024
arrow
Subscribe Now