FDA recall Z-1328-2020

Product

CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

Reason for recall

When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.

Distribution

Worldwide distribution  US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MI, MN, MO, MT, NC, NJ, NY, OH, TX, UT, VA and countries of Canada, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, China, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Dominican Republic, Egypt, Ethiopia, France, Germany, Ghana, Hungary, Iran, Italy, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Nigeria, Oman, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Viet Nam.

Key facts

Status

Ongoing

Initiation date

2019-12-19

Report date

2020-02-26

Termination date

2020-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hamburg, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1328-2020