Hochdorf, N/A, Switzerland
Swissray Medical recalls
2 recalls recorded since 2018, most recently on 18 November 2016. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 November 2016
- Reason
- Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
- Distribution
- Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3191-2018
- ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Ongoing Class II Medical devices
- Recall started
- 9 August 2016
- Reason
- Possible injury due to movement of the arm, calibration loss and communication loss.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3248-2018
- ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.