Philips North America BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261; Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;
Brand
Philips North America
Lot Codes / Batch Numbers
All serial numbers are affected. No UDI-DI available for this product.
Products Sold
All serial numbers are affected. No UDI-DI available for this product.
Philips North America is recalling BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824 due to Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, co. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026