FDA recall Z-0703-2019

Product

Discover VH/Millennium VG Nuclear Medicine Imaging System

Reason for recall

A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan.

Distribution

Worldwide

Key facts

Status

Completed

Initiation date

2017-10-30

Report date

2019-01-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0703-2019