Recall Z-0488-2019— Sedecal S.A.

Name: FDA recall Z-0488-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-18

Class II · Ongoing

Class II FDA medical device recall by Sedecal S.A., initiated 2018-07-18. It names one FDA 510(k) clearance: K133782. Product: Sedecal NOVA FA DR System. for diagnostic radiography.. Reason: 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..

Recalling firm: Sedecal S.A.
Classification: Class II
Status: Ongoing
Initiated: 2018-07-18
Firm location: Algete, N/A, Spain

510(k) clearances named in this recall

1 on FDA's record

K133782 — NOVA FA DR SYSTEMSedecal., Sa.·cleared 2014-03-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.