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Terminated

Velara Generator with an old Firmware version used with the Philips Integris BH5000

FDA Recall Z-1062-2017 · Posted None

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeIZI
Date Initiated2016-12-09
Date Terminated2020-07-30
Product Quantity59 devices (this number represents all products listed in recall)

Reason for Recall

System may lock up.

Firm Action

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.

Root Cause

Device Design

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041949ALLURA XPER FD10Philips Medical Systems North America Co. · 2004-07-30K033737ALLURA XPER FD20Philips Medical Systems North America, Inc. · 2003-12-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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