PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 2025-05-21 Health serious FDA
Health · FDA · Recall #FDA-Z-1783-2025
SmartPath to dStream for 3.0T, Model Number: 782145; Recall
Issued May 21, 2025 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
In May 2025, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled the SmartPath to dStream for 3.0T, Model Number: 782145;, 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
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
What you should do
- 1 Stop using SmartPath to dStream for 3.0T, Model Number: 782145; 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
- May 21, 2025
- Units affected
- Not reported
- Sold at
- US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus,
- Recall number
- FDA-Z-1783-2025
- 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 691st Health recall we've logged in 2025.