Recall Z-3248-2018— Swissray Medical

Name: FDA recall Z-3248-2018
Creator: U.S. Food and Drug Administration
Published: 2016-08-09

Class II · Ongoing

Class II FDA medical device recall by Swissray Medical, initiated 2016-08-09. It names one FDA 510(k) clearance: K052943. Product: ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging. Reason: Possible injury due to movement of the arm, calibration loss and communication loss..

Recalling firm: Swissray Medical
Classification: Class II
Status: Ongoing
Initiated: 2016-08-09
Firm location: Hochdorf, 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, ddR Formula B Product Usage: X-ray system used for imaging

Reason for recall

Possible injury due to movement of the arm, calibration loss and communication loss.

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