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

FDA Recall #Z-1062-2017 — Class II — December 9, 2016

Recall #Z-1062-2017 Date: December 9, 2016 Classification: Class II Status: Terminated

Product Description

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

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.

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