Skip to content
Recall Observatory FDA recall evidence

Device 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)

Z-1061-2017

December 09, 2016

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 76080
Status
Terminated
Classification
Class II
Quantity
59 devices (this number represents all products listed in recall)
Official record key
device-enforcement:Z-1061-2017

Official wording

Reason: System may lock up.

Code information: Velara Generator with 12nc number: 989000070011, 989000070122, 989000070123, 989000070124, 989000070125, 989000070126, 989000070321

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    System may lock up.