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: 75 US; 442 OUS Lot/code info: a. Model No. 781277; UDI-DI N/A. b. Model No. 781177; UDI-DI N/A. c. Model No. 781278; UDI-DI 00884838004139. d. Model No. 781344; UDI-DI N/A. e. Model No. 781345; UDI-DI N/A. All units affected
00884838004139
Official record: FDA (Device enforcement) ↗
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