FDA Device recall Z-3248-2018
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
- FDA Device
- Class II
- ongoing
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging by Swissray Medical, citing possible injury due to movement of the arm, calibration loss and communication loss.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3248-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2016-08-09 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Swissray Medical |
| Distribution | US |
Product
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
Reason
Possible injury due to movement of the arm, calibration loss and communication loss.
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, 1702001, 1702002, 1702003 & 1702004 |
|---|
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-3248-2018%22
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