Recall Z-1585-2023 ยท JAK System, X-Ray, Tomography, Computed
Philips North America
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
| Date | May 12, 2023 (initiated Mar 20, 2023) |
| Status | Open, Classified |
| Reason | Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury |
| Root cause | Under Investigation by firm |
| Action | Philips Medical issued Urgent Medical Device Correction Letter Multi-Function Switch Unload Pedal Foot Entrapment on 3/20/23 to US consignees via Certified United States Postal Service (USPS) with delivery confirmation. International global markets were notified of the issue and instructed to distribute the FSN to affected consignees in accordance with local requirements. Letter states reason for recall, health risk and action to take: Immediately stop using the Unload Pedal of the Foot Switch until Philips installs a solution on your system. " Instead of using the Unload Pedal, please use th |
| Quantity | 10 units US; 36 units OUS |
| Distribution | Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, MI, MO, NY, TN, TX, VT and the countries of Australia, Chile, Costa Rica, Czech Republic, Dominican, Republic Germany, India, Israel, Japan, Lithuania, Philippines, Poland, Sint Maarten (Dutch part), South Africa, Thailand, |
| FDA record | Open on fda.gov |