Z-0923-2017Class II

Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including...

Name: Z-0923-2017 Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including...
Creator: Philips Electronics North America Corporation
Published: 2016-12-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-12-01 / Terminated / root cause: manufacturing process

FDA source

Philips Electronics North America Corporation began a recall of Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA... on 2016-12-01. FDA classified it as Class II and gives the reason as "Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled". 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-0923-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-01
Posted: 2017-01-20
Terminated: 2017-08-10
Recalling firm: Philips North America LLC
Product: Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were notified of the recall via letter sent on 12/1/16. The letter explains the issue and the action that Philips plans to take.
Quantity in commerce: 1
Distribution: US: WA OUS: China, Spain, Korea, Republic of, Germany
Product codes and lots: 783

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0923-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0922-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-20
Z-0923-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-20
Z-0924-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-20
Z-0925-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-20

Product code IZI

K041949Class IIAllura Xper Fd10Philips Medical Systems North America Co. / cleared 2004-07-30

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)