Z-1904-2021Class II

Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028...

Name: Z-1904-2021 Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028...
Creator: Philips Medical Systems Nederlands
Published: 2016-06-23
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2016-06-23 / Terminated / root cause: design

FDA source

Philips Medical Systems Nederlands began a recall of Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058 on 2016-06-23. FDA classified it as Class II and gives the reason as "Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement...". 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-1904-2021
Classification: Class II
Status: Terminated
Initiated: 2016-06-23
Posted: 2021-06-21
Terminated: 2023-02-08
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.
Root cause tag: design
FDA root cause: Component design/selection
Action: On April 23, 2021, Philips Healthcare issued an Urgent Medical Device Correction notice to customers via letter notifying them that Philips Healthcare has discovered through trend analysis an increase in the failure rate of certain low-voltage DC power supplies (DCPS) used in these products. Each system contains multiple DCPS, some of which may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering. HOW TO IDENTIFY AFFECTED PRODUCTS: For systems mentioned above, If 'Rev 8.2.16 or Rev 8.2.17 appears in the lower (black) area of the start-up screen, the system is affected. Philips will be notifying customers with affected systems. ACTION TO BE TAKEN BY CUSTOMER / USER: The likelihood of a system failure occurring is remote, and the users are recommended to follow their pre-established procedures for managing potential patient safety in the event that the system shuts down. ACTIONS PLANNED BY PHILIPS: Philips will replace the affected DCPS. This service will be provided free of charge for all affected systems. A Philips Healthcare service representative will contact customers with affected devices to arrange for the service. .
Quantity in commerce: 42 devices
Distribution: Worldwide distribution. US states of: AL, AZ, FL, GA, IL, MA, MO, NJ, OR, and VA; Netherlands, United Kingdom, Poland, Spain, France, Czech Republic, India, Brazil, Singapore, Japan, Colombia, United Arab Emirates, China, Russian Federation, Oman, and Mexico.
Product codes and lots: Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058. Date(s) of Distribution: 16-SEP-2014 - 04-MAY-2016. System equipment numbers: 64937259 65862117 63304032 63151474 63250793 63303889 63304149 64140063 63855729 63516113 64077887 66407452 66350303 65342973 63210187 63511276; 66923399 66422060 64085323 61099178 64103799 67936786 66730784 66736708 66628236 63883590 64916638 64927462 65345691 66517161 66403768 63218881 67360962 69856976 65258983 66167983 64778594 61655917 65206981 67874859

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1904-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1904-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21

Product code OWB

K141979Class IIAllura Xper Fd Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV / cleared 2014-08-19

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)