Medrad Counterpoise System

• 2 recalls, same reason

  • Terminated Z-2961-2018 FDA Class II ·initiated 28 Jun 2018
  • Terminated Z-2960-2018 FDA Class II ·initiated 28 Jun 2018

  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.

• • Terminated Z-0089-06 FDA Unclassified (pre-2012) ·initiated 7 Oct 2005

  overhead system can fall due to the failure of a retaining ring.

510(k) Number

K944983 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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