Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
Reported: February 7, 2024 Initiated: January 3, 2024 #Z-0951-2024
Product Description
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
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
- 1 US; 347 OUS
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.. Recalled by Philips North America. Units affected: 1 US; 347 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-0951-2024.
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