Recall Z-0764-2016— Philips Electronics North America Corporation
Class II · Terminated
Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-11-03, terminated 2016-08-19. It names one FDA 510(k) clearance: K033737. Product: Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.. 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)..
- Recalling firm
- Philips Electronics North America Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-03
- Terminated
- 2016-08-19
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.