Recall – X-ray System may cause injury due to software error

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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