Z-3248-2018 Class II Ongoing
FDA device recall Z-3248-2018 was initiated by Swissray Medical on Aug 9, 2016 and is designated Class II. Reason for recall: Possible injury due to movement of the arm, calibration loss and communication loss. The recall status is ongoing. Affected quantity: 26 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 3, 2018
- Initiation Date
- Aug 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