FDA recall Z-1039-2019

Shimadzu Medical Systems Usa Com · Class II · device

Product

SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).

Reason for recall

In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. However, for systems within a specified manufacture period, we have identified that even when letting go of the handle, the systems brakes are not applied. In this event, if the Operator releases the handle when the device is moving, the unit will continue to coast.

Distribution

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2019-01-14
Report date
2019-03-27
Termination date
2023-04-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Torrance, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1039-2019