Z-1491-2020Class II

Poly G Integris H5000, System code 72246

Name: Z-1491-2020 Poly G Integris H5000, System code 72246
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 Poly G Integris H5000, System code 72246 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-1491-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-30
Posted: 2020-03-13
Terminated: 2022-11-17
Recalling firm: Philips North America LLC
Product: Poly G Integris H5000, System code 72246
Product code: IZI System, X-Ray, Angiographic
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: 1
Distribution: Nationwide domestic distribution. Foreign distribution worldwide.
Product codes and lots: System equipment number 519212

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1491-2020
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 IZI

K971365Class IIPhilips Integris H5000Philips Medical Systems North America, Inc. / cleared 1997-05-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)