FDA Enforcement
Class II
Ongoing
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
Recall: Z-1586-2023
·
Reported May 24, 2023
Enforcement
- Recall Number
- Z-1586-2023
- Event ID
- 92117
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 24, 2023
- Initiation Date
- March 20, 2023
- Classification Date
- May 12, 2023
- Address
- 222 Jacobs St, N/A, Cambridge, MA, 02141-2296, United States
Description
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
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
Code Info
UDI-DI:(01)00884838085015(21) + Serial number US Serial Numbers: 33041, 500301, 500252. OUS Serial Numbers: 33040, 500408
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, United Kingdom, Utd. Arab. Emir.
Quantity
3 units US ;2 units OUS