Recall Z-1062-2017 ยท IZI System, X-Ray, Angiographic
Philips Electronics North America Corporation
Velara Generator with an old Firmware version used with the Philips Integris BH5000
| Date | Dec 9, 2016 |
| Status | Terminated |
| Reason | System may lock up. |
| 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 | 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 |
| FDA record | Open on fda.gov |