Recall Z-3191-2018— Swissray Medical

Name: FDA recall Z-3191-2018
Creator: U.S. Food and Drug Administration
Published: 2016-11-18

Class II · Ongoing

Class II FDA medical device recall by Swissray Medical, initiated 2016-11-18. It names one FDA 510(k) clearance: K052943. Product: ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging. Reason: Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly..

Recalling firm: Swissray Medical
Classification: Class II
Status: Ongoing
Initiated: 2016-11-18
Firm location: Hochdorf, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K052943 — DDRFORMULA AND DDRFORMULA PLUSSwissray Medical AG·cleared 2005-12-15

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

ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging

Reason for recall

Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.

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