FDA recall Z-2523-2020

Product

EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.

Reason for recall

Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CT, FL, GA, HI, IL, LA, MA, MD, MI, MS, MT, NC, NY, TN, TX and the country of Panama.

Key facts

Status

Terminated

Initiation date

2020-06-02

Report date

2020-07-15

Termination date

2021-02-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2523-2020