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FDA (Device enforcement)Recalled 2016-12-09closedclass ii

Philips Electronics North America Corporation: Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10

Is my product affected?

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)

  • UPC 989000070011
  • UPC 989000070122
  • UPC 989000070123
  • UPC 989000070124
  • UPC 989000070125
  • UPC 989000070126
  • UPC 989000070321

Check against the official notice below — it lists the full affected range.

What happened

Philips Electronics North America Corporation has recalled 59 Velara Generators with outdated firmware versions that were used with specific Philips Allura Xper imaging systems. The affected equipment includes Velara Generators with certain model numbers (989000070011, 989000070122, 989000070123, 989000070124, 989000070125, 989000070126, and 989000070321) and is distributed across multiple U.S. states and numerous countries worldwide including Brazil, France, Germany, Japan, Mexico, and the United Kingdom.

The recalled devices may experience system lock-ups during operation. According to the recall record, no remedy information is specified for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

System may lock up.

Details from the source

Reason for recall: System may lock up. 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 Quantity: 59 devices (this number represents all products listed in recall) Lot/code info: Velara Generator with 12nc number: 989000070011, 989000070122, 989000070123, 989000070124, 989000070125, 989000070126, 989000070321

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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