—#152106

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)

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033737, K041949
Affected lot / code info: Velara Generator with 12nc number: 989000070011, 989000070122, 989000070123, 989000070124, 989000070125, 989000070126, 989000070321

Why it was recalled

System may lock up.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2016-12-09
Terminated: 2020-07-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152106. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.