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Recall Observatory FDA recall evidence

Device product

Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.

Z-0764-2016

November 03, 2015

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 72571
Status
Terminated
Classification
Class II
Quantity
15 subject to correction and removal
Official record key
device-enforcement:Z-0764-2016

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).