Swissray Medical: Medical Device Recall in 2018 - (Recall #: Z-3248-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging

Product Classification:

Class II

Date Initiated: August 9, 2016

Date Posted: October 3, 2018

Recall Number: Z-3248-2018

Event ID: 81045

Reason for Recall:

Possible injury due to movement of the arm, calibration loss and communication loss.

Status: Ongoing

Product Quantity: 26 units

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

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated