—#205400

Product

BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K080927
Affected lot / code info: All serial numbers are affected. No UDI-DI available for this product.

Why it was recalled

Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.

Root cause (FDA determination)

Component design/selection

Action the firm took

On December 15, 2023, the firm notified affected customers via URGENT Medical Device Correction letters. Customers were instructed to not position a patient's lower limbs directly under the detector below the Center of Gantry bore. Customers should circulate the notice to all users of the device for awareness and retain the letter with affected systems until the correction is complete. 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. If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377). As of 3/14/24, Philips will begin inspecting all affected devices in the field to ensure alignment of the radial leadscrew. Systems that are identified as having a misaligned leadscrew will undergo a report. Additionally, Philips will begin intsallation of a secondary catching mechanism (safety plate) starting in May 2024 in all devices. The firm will contact customers to coordinate these activities.

Recalling firm

Firm: Philips North America
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2296

Distribution

Distribution pattern: Domestic distribution nationwide. International distribution worldwide.

Timeline

Recall initiated: 2023-12-15
Posted by FDA: 2024-02-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205400. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.