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: 119 US; 1,807 OUS Lot/code info: a. Model No. 781196; UDI-DI N/A. b. Model No. 781343; UDI-DI 00884838055292. c. Model No. 781296; UDI-DI 00884838004108. All units are affected.
00884838055292, 00884838004108
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.