Mavig Angio Shield Models 6290 & 6272

• • Terminated Z-2962-2018 FDA Class II ·initiated 28 Jun 2018 ·via K934206, on the same 510(k)

  The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K934206 ↗

FDA Product Code

KPY

Device Class

Class I

Regulation

21 CFR Part 892.6500

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Hanel Mavig Monitor Suspension System

  Class II

  FDA 510(k) K954945 Active Cleared 29 Jan 1996

• Mavig Lower Body Protection Systems, Assembly Models 6265, 6266, 6267, 6268, 6269/0, 629/1, and 6269/2

  Class I

  FDA 510(k) K945238 Active Cleared 15 Dec 1994