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: 21 US; 265 OUS Lot/code info: a. Model No. 781270; UDI-DI 00884838095083. b. Model No. 782113; UDI-DI 00884838098909. c. Model No. 782129; UDI-DI 00884838105805. All units affected
00884838095083, 00884838098909, 00884838105805
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.