FDA recall Z-0297-2019

Product

Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Wireless (model number 10893300) with Tube stand 3D V (model number 7042042)

Reason for recall

Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning

Distribution

US nationwide distribution

Key facts

Status

Terminated

Initiation date

2018-08-03

Report date

2018-11-07

Termination date

2019-11-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0297-2019