Recall Z-0956-2024— Philips North America
Class II · Ongoing
Class II FDA medical device recall by Philips North America, initiated 2024-01-03. FDA's recall record names no specific 510(k) clearance for this event. Product: SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.. Reason: 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..
- Recalling firm
- Philips North America
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-03
- Firm location
- Cambridge, MA, United States
Product description
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.