Philips Electronics North America Corporation: Medical Device Recall in 2017 - (Recall #: Z-1061-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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)

Product Classification:

Class II

Date Initiated: December 9, 2016

Date Posted: February 1, 2017

Recall Number: Z-1061-2017

Event ID: 76080

Reason for Recall:

System may lock up.

Status: Terminated

Product Quantity: 59 devices (this number represents all products listed in recall)

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

Voluntary or Mandated:

Voluntary: Firm initiated