PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Veradius Unity, Model #718132

Is my product affected?

Veradius Unity, Model #718132

• UPC 459801238191
• UPC 459801238231

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

What happened

Philips Medical Systems Nederland B.V. has recalled the Veradius Unity Model #718132 due to a firmware issue affecting the wireless foot switch. The wireless foot switch can suddenly stop responding during use, which could cause delays or interruptions to medical procedures if the hand switch is not being used or if a wired foot switch is not connected to the system. The affected wireless foot switches have lot/code numbers 459801238191 and 459801238231.

The recalled units were distributed domestically to multiple U.S. states including Arizona, California, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington, and West Virginia, as well as internationally. A total of 12 units were distributed in the U.S. and 44 units were distributed outside the U.S. The source does not specify what remedy consumers should take.

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

Hazard

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

Details from the source

Reason for recall: Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system. Distribution: Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV NY OH PA TN TX VA WA WV. Worldwide foreign distribution. Quantity: 12 US; 44 ROW Lot/code info: Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231

Source

Official record: FDA (Device enforcement) ↗

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

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