FDA recall Z-1898-2024

Product

FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33

Reason for recall

Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury

Distribution

US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.

Key facts

Status

Ongoing

Initiation date

2024-04-11

Report date

2024-06-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1898-2024