FDA recall Z-1462-2024

Agfa N.V. · Class II · device

Product

Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400

Reason for recall

Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Argentina, Australia, Austria, Belgium, Chile, China, Colombia, Czech Republic, Finland, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Mexico, New Zealand, Norway, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Kingdom.

Key facts

Status
Ongoing
Initiation date
2024-02-23
Report date
2024-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mortsel, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1462-2024