Z-1062-2017Class II

Velara Generator with an old Firmware version used with the Philips Integris BH5000

Name: Z-1062-2017 Velara Generator with an old Firmware version used with the Philips Integris BH5000
Creator: Philips Electronics North America Corporation
Published: 2016-12-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-12-09 / Terminated / root cause: design

FDA source

Philips Electronics North America Corporation began a recall of Velara Generator with an old Firmware version used with the Philips Integris BH5000 on 2016-12-09. FDA classified it as Class II and gives the reason as "System may lock up". 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-1062-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-09
Posted: 2017-01-20
Terminated: 2020-07-30
Recalling firm: Philips North America LLC
Product: Velara Generator with an old Firmware version used with the Philips Integris BH5000
Product code: IZI System, X-Ray, Angiographic
Reason for recall: System may lock up.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified of the recall by letter, sent via certified mail on 12/9/16. Philips will upgrade the firmware of the Velara Generator, allowing the Velara Generator to recover in case of intermittent shortcuts. This service will be provided free of charge for all affected systems and will start effective January 2017. A Philips service representative will contact customers with affected devices to arrange for the service.
Quantity in commerce: 59 devices (this number represents all products listed in recall)
Distribution: US: AL, CA, DC, IL,GA, KS, MD, MO, NC, NY, OH, PA, RI, SC, TX, WA OUS: Brazil, Bulgaria, Costa Rica, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Russian Federation, Singapore, Spain, Sweden, Switzerland Switzerland, Turkey, United Kingdom
Product codes and lots: Velara Generator with 12nc number: 989000070011, 989000070122, 989000070123, 989000070124, 989000070125, 989000070126, 989000070321

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1062-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1061-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-20
Z-1062-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-20

Product code IZI

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)