SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
Reported: February 7, 2024 Initiated: January 3, 2024 #Z-0956-2024
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.
Details
- Recalling Firm
- Philips North America
- Units Affected
- 21 US; 265 OUS
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.. Recalled by Philips North America. Units affected: 21 US; 265 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 7, 2024. Severity: Moderate. Recall number: Z-0956-2024.
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