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Recall Observatory FDA recall evidence

Device product

ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging

Z-3191-2018

November 18, 2016

Class II

Product summary

Firm
Swissray Medical
Event
Event 80981
Status
Ongoing
Classification
Class II
Quantity
27 devices in US
Official record key
device-enforcement:Z-3191-2018

Official wording

Reason: Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.

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

Distribution pattern: Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.