Company: Swissray
Date of Enforcement Report 10/3/2018
Class lI:

PRODUCT
ddR Formula B X-ray System, ddR Formula B

Product Usage: X-ray system used for imaging.

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

Recall Number: Z-3248-2018

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

RECALLING FIRM/MANUFACTURER
Swissray, Hochdorf, Switzerland on 8/9/2016 Voluntary: Firm Initiated

VOLUME OF PRODUCT IN COMMERCE
26

DISTRIBUTION
U.S. Nationwide

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