Z-1494-2020Class II

Cardio Vascular-Allura Centron, system code 722400

Name: Z-1494-2020 Cardio Vascular-Allura Centron, system code 722400
Creator: Philips North America, LLC
Published: 2019-12-30
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-12-30 / Terminated / root cause: design

FDA source

Philips North America, LLC began a recall of Cardio Vascular-Allura Centron, system code 722400 on 2019-12-30. FDA classified it as Class II and gives the reason as "A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible". 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-1494-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-30
Posted: 2020-03-13
Terminated: 2022-11-17
Recalling firm: Philips North America LLC
Product: Cardio Vascular-Allura Centron, system code 722400
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Root cause tag: design
FDA root cause: Component design/selection
Action: On December 30, 2019, the firm notified customers via Medical Device Correction letter. Customers were informed of the product issue and advised to do the following: If the capacitor of the Velara X-Ray fails as described (capacitor failure after large number of surges in a short period of time), please switch off the system, take it out of service immediately, and contact your local Philips representative. The firm will be resolving the issue by replacing a Printed Circuit Board (PCB) in the convertor, which prevents the capacitor from failing. PCB replacements started in January 2020. Customers will be contacted by their local Philips representatives to schedule a date for the PCB replacement. Customers with further questions should contact the Technical Support Line: 1-800-722-9377.
Quantity in commerce: 87
Distribution: Nationwide domestic distribution. Foreign distribution worldwide.
Product codes and lots: Not distributed in US. Serial numbers 132 133 49 66 71 135 31 36 79 69 137 149 147 109 136 108 103 93 53 127 129 129 55 74 2 57 106 56 86 68 157 78 64 63 23 51 100 97 102 113 90 44 30 101 77 83 67 151 22 70 96 116 131 35 82 9 91 43 61 161 28 34 27 19 144 92 168 172 173 122 197 139 6 76 176 16 130 60 80 184 112 81 89 42 110 155 33

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1494-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1486-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1487-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1488-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1489-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1490-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1491-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1492-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1493-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1494-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)