Z-3248-2018 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 3, 2018
- Initiation Date
- August 9, 2016
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 units
Product Description
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
Reason for Recall
Possible injury due to movement of the arm, calibration loss and communication loss.
Distribution Pattern
US Nationwide
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, 1702001, 1702002, 1702003 & 1702004