PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 2022-02-23 Health serious FDA
Health · FDA · Recall #FDA-Z-0647-2022
Zenition 50, Model #718096 Recall
Issued February 23, 2022 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
In February 2022, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled the Zenition 50, Model #718096, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Zenition 50, Model #718096 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Health
- Recall date
- February 23, 2022
- Units affected
- Not reported
- Sold at
- 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
- Recall number
- FDA-Z-0647-2022
- Made in
- Netherlands
- Issuing agency
- FDA
In context
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 17 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.