BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
Recall
- Recall Number
- Z-0931-2024
- Event Number
- 93767
- Firm
- Philips North America
- FEI Number
- 3006648320
- Product Code
- KPS
- Status
- Open, Classified
- Root Cause
- Component design/selection
- Initiated
- December 15, 2023
- Posted
- February 2, 2024
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2296
Description
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
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.
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.
Domestic distribution nationwide. International distribution worldwide.
106 US; 241 OUS