Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & ...
FDA Recall #Z-1061-2017 — Class II — December 9, 2016
Product Description
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)
Reason for Recall
System may lock up.
Recalling Firm
Philips Electronics North America Corporation — Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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
Code Information
Velara Generator with 12nc number: 989000070011, 989000070122, 989000070123, 989000070124, 989000070125, 989000070126, 989000070321
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.