FDA recall Z-2738-2024

Product

DR 800. Digital Radiography X-ray System.

Reason for recall

Potential for the front lever chain of the DR 800 table to fail.

Distribution

Worldwide - US Nationwide distribution in the states of CA, FL, IL, IN, KS, LA, MA, MO, NJ, NC, OH, OK, SC, VA, WV, WI; and the countries of AU, BE, BW, CA, CO, CZ, DE, ES, FR, GB, GR, IL, IN, IT, KZ, MX, PL, RS, UZ, ZA.

Key facts

Status

Ongoing

Initiation date

2024-07-29

Report date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mortsel, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2738-2024