FDA recall Z-1806-2020

Product

Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.

Reason for recall

If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.

Distribution

Worldwide distribution - US Nationwide distribution including the states of CA, ME, RI, TX, WI and the countries of Canada, Australia, Austria, France, Germany, Greece, Hungary, Ireland, Netherlands, Portugal, Slovenia, United Kingdom.

Key facts

Status

Terminated

Initiation date

2020-04-07

Report date

2020-05-06

Termination date

2023-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1806-2020