Z-0764-2016Class II

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

Name: Z-0764-2016 Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications
Creator: Philips Electronics North America Corporation
Published: 2015-11-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-11-03 / Terminated / root cause: design

FDA source

Philips Electronics North America Corporation began a recall of Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications on 2015-11-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0764-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-03
Posted: 2016-02-05
Terminated: 2016-08-19
Recalling firm: Philips North America LLC
Product: Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
Product code: OWB Interventional Fluoroscopic X-Ray System
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).
Root cause tag: design
FDA root cause: Device Design
Action: The letters for the customers in the United States were sent on 11/3/2015, via certified return receipt and were addressed to the Risk Manager. Philips will perform a test on the 15 affected Allura Xper R8.2 FD 20C systems to see if the motion controller amplifier of the brake motor works correctly. If the test will not pass, the motor will be replaced. The Recall Package is sent to all Key Markets worldwide. The Key Market of an affected country will contact the facility where these systems were installed.
Quantity in commerce: 15 subject to correction and removal
Distribution: 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.
Product codes and lots: Ceiling version only.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0764-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0764-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-05
Z-0765-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-05

Product code OWB

K033737Class IIAllura Xper Fd20Philips Medical Systems North America, Inc. / cleared 2003-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)