Recall Z-1061-2017
Philips Electronics North America Corporation · initiated December 9, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)
Codes / lots: Velara Generator with 12nc number: 989000070011, 989000070122, 989000070123, 989000070124, 989000070125, 989000070126, 989000070321
Reason for recall
System may lock up.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1061-2017
- Initiated
- December 9, 2016
- Terminated
- July 30, 2020
- Product code
- IZI – System, X-Ray, Angiographic
- 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
- Recalling firm
- Philips Electronics North America Corporation, Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1062-2017 Class II | Velara Generator with an old Firmware version used with the Philips Integris BH5000System may lock up. | 12/09/2016Terminated |