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.
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. Distribution: Worldwide - US Nationwide distribution. Quantity: 23 US; 51 OUS Lot/code info: Model No. 781346 UDI-DI N/A All units affected
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.