Sedecal S.A.: Medical Device Recall in 2018 - (Recall #: Z-0488-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Sedecal NOVA FA DR System. for diagnostic radiography.

Product Classification:

Class II

Date Initiated: July 18, 2018

Date Posted: November 28, 2018

Recall Number: Z-0488-2019

Event ID: 81377

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.

Status: Ongoing

Product Quantity: 145 units

Code Information:

Serial Numbers 07360816 through 17291024

Distribution Pattern:

US and Canada

Voluntary or Mandated:

Voluntary: Firm initiated