FDA recall Z-0488-2019

Product

Sedecal NOVA FA DR System. for diagnostic radiography.

Reason for recall

A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.

Distribution

US and Canada

Key facts

Status

Ongoing

Initiation date

2018-07-18

Report date

2018-11-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Algete, N/A, Spain

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0488-2019