FDA recall Z-3248-2018

Product

ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging

Reason for recall

Possible injury due to movement of the arm, calibration loss and communication loss.

Distribution

US Nationwide

Key facts

Status

Ongoing

Initiation date

2016-08-09

Report date

2018-10-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hochdorf, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3248-2018