FDA Device recall Z-3191-2018
ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
- FDA Device
- Class II
- ongoing
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging by Swissray Medical, citing potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3191-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2016-11-18 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Swissray Medical |
| Distribution | US |
Product
ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Reason
Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
Identifiers
| code_info | Serial Numbers within U.S.A commerce - 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3191-2018%22
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