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Recall Observatory FDA recall evidence

Device product

Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.

Z-0765-2016

November 03, 2015

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 72571
Status
Terminated
Classification
Class II
Quantity
2 subject to correction and removal
Official record key
device-enforcement:Z-0765-2016

Official wording

Reason: Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position).

Code information: Ceiling version only.

Distribution pattern: Worldwide Distribution. US states of TN and IN and the countries of Australia, Belgium, Egypt, France, Germany, Japan, Republic of Korea, Netherlands, and Saudi Arabia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position).