FDA Devices Moderate Class II Terminated

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

Reported: February 1, 2017 Initiated: December 9, 2016 #Z-1062-2017

Product Description

Reason for Recall

System may lock up.

Details

Recalling Firm: Philips Electronics North America Corporation
Units Affected: 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
Location: Andover, MA

Frequently Asked Questions

What product was recalled? ▼

Velara Generator with an old Firmware version used with the Philips Integris BH5000. Recalled by Philips Electronics North America Corporation. Units affected: 59 devices (this number represents all products listed in recall).

Why was this product recalled? ▼

System may lock up.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 1, 2017. Severity: Moderate. Recall number: Z-1062-2017.