Z-3191-2018 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2018
- Initiation Date
- November 18, 2016
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 devices in US
Product Description
ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Reason for Recall
Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa.
Code Information
Serial Numbers within U.S.A commerce - 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007, 1402008, 1402009, 1402011, 1402012, 1402015, 1502001, 1502002, 1502004, 1502005, 1502006, 1502007, 1602001, 1602002, 1602003, 1602005, 1602006, 1602007 & 1602008 Serial Numbers Outside of U.S.A commerce - 1402005, 1402017, 1502009, 1502010, 1502011, 1302004, 1302006, 1302007, 1302008, 1302010, 1402003, 1402004, 1402010, 1402013, 1402014, 1402016, 1502008 & 1602004