Z-0728-2016Class II

INTEGRIS Allura 15-12 (biplane)

Name: Z-0728-2016 INTEGRIS Allura 15-12 (biplane)
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 INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and... on 2015-11-03. FDA classified it as Class II and gives the reason as "The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images". 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-0728-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-03
Posted: 2016-01-30
Terminated: 2020-09-15
Recalling firm: Philips North America LLC
Product: INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Philips, issued "URGENT-Field Safety Notices" dated 10/26/2015 and 11/19/2015 to its customers. The notices described the product, problem and actions to be taken. The customers were instructed to ensure the audible signal (X-ray buzzer) is always enabled, to activate only ONE fluoroscopy pedal at time, and to configure the footswitch to the default Philips configuration. Customers were also instructed to review the information with all members of your staff who need to be aware; retain a copy with the equipment IFU and complete and return the Confirmation Respond form to Mail Stop 4302, 3000 Minuteman Road, Andover, MA 01810 or email: [email protected]. Philips is tracking the delivery of these notices via certified return receipt. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
Quantity in commerce: 13297 in total
Distribution: Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
Product codes and lots: All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0728-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0702-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0703-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0704-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0705-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0706-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0707-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0708-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0709-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0710-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0711-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0712-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0713-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0714-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0715-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0716-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0717-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0718-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0719-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0720-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0721-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0722-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0723-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0724-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0725-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0726-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0727-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0728-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0729-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30
Z-0730-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30

Product code OWB

K002016Class IIPhilips Integris AlluraPhilips Medical Systems North America, Inc. / cleared 2000-09-06

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)