FDA recall Z-1944-2020

Beckman Coulter Inc. · Class II · device

Product

iChem¿VELOCITY Urine Chemistry System-

Reason for recall

A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computers metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the devices CD-ROM.

Distribution

US Distribution: Nationwide Foreign Distribution: Worldwide

Key facts

Status
Terminated
Initiation date
2020-03-30
Report date
2020-05-20
Termination date
2023-08-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1944-2020