Z-1585-2023 Class II Ongoing
FDA device recall Z-1585-2023 was initiated by Philips North America on March 20, 2023 and is designated Class II. Reason for recall: 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 The recall status is ongoing. Affected quantity: 10 units US; 36 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- March 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units US; 36 units OUS
Product Description
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
Reason for Recall
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
Distribution Pattern
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.
Code Information
UDI-DI: (01)00884838105508(21) + Serial number US Serial Numbers: 550243, 34111, 34092, 34066, 34064, 34047, 34042, 34025, 34031, 34033 OUS Serial Numbers: System Serial Number 550263 550249 550239 550215 550211 550091 550188 550187 550186 550174 550172 552041 550164 34107 550140 34062 550099 550082 550071 550068 550059 34020 550038 550040 550021 550036 550018 550014 550011 550010 550009 550008 550007 550240 550126 550241