Z-0346-2016Class II

Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21...

Name: Z-0346-2016 Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21...
Creator: Philips Medical Systems, Inc.
Published: 2015-02-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-02-03 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems, Inc. began a recall of Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper... on 2015-02-03. FDA classified it as Class II and gives the reason as "Monitor Ceiling Suspension system may fall". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0346-2016
Classification: Class II
Status: Terminated
Initiated: 2015-02-03
Posted: 2015-12-01
Terminated: 2017-01-18
Recalling firm: Philips North America LLC
Product: Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper FD24 Allura Xper FD25 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Monitor Ceiling Suspension system may fall
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Philips sent an Urgent Field Safety Notice letter dated January 8, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. The actuator of all affected systems will be replaced free of charge. All affected customers will be contacted in order to schedule the implementation of this action. For questions contact your local Philips representatice: Technical Support Line: 1-800-722-9377.
Quantity in commerce: 9 units
Distribution: Worldwide Distribution - US Nationwide and the countries of: Canada,Australia, Austria, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, South Africa, Spain, Switzerland and United Kingdom.
Product codes and lots: System : S/N : Model: 722003 30 Allura Xper FD10 722010 670 Allura Xper FD10 722011 167 Allura Xper FD10/10 722012 1951 Allura Xper FD20 722012 536 Allura Xper FD21 722012 504 Allura Xper FD22 722012 748 Allura Xper FD23 722012 536 Allura Xper FD24 722012 579 Allura Xper FD25

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0346-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0346-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-11-30
Z-0347-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-11-30
Z-0348-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-11-30
Z-0349-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-11-30
Z-0350-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-11-30
Z-0351-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-11-30
Z-0352-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-11-30
Z-0353-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-11-30
Z-0354-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-11-30

Product code OWB

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)