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Open, Classified

Sedecal NOVA FA DR System. for diagnostic radiography.

FDA Recall Z-0488-2019 · Posted None

Recalling FirmSedecal S.A.
Recall StatusOpen, Classified
Product CodeMQB
Date Initiated2018-07-18
Product Quantity145 units

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.

Firm Action

Initial communication from SEDECAL to all our distributors was performed on 07/18/2018 by email. The letter explained the problem and requested the consignee cease use of the unit if they observe an abnormal displacement in the vertical axis or any suspicious noise during the vertical movement.

Root Cause

Device Design

Distribution Pattern

US and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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