PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Zenition 50, Model #718096

Is my product affected?

Zenition 50, Model #718096

• UPC 459801238191
• UPC 459801238231

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

What happened

Philips Medical Systems Nederland B.V. is recalling the Zenition 50 (Model #718096) due to a firmware issue that can cause the wireless foot switch to suddenly stop responding. If the wireless foot switch fails and the hand switch is not being used or the wired foot switch is not connected to the system, there could be a delay or interruption during medical procedures.

The recall affects 16 units in the United States (distributed to 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) and 76 units distributed internationally. The affected wireless foot switches have lot/code numbers 459801238191 or 459801238231.

The source document does not specify a remedy for affected consumers.

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: 16 US; 76 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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