Device product
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
Z-0951-2024
Product summary
- Event
- Event 93787
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 US; 347 OUS
- Official record key
device-enforcement:Z-0951-2024
Official wording
Reason: 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.
Code information: a. Model No. 781271; UDI-DI 00884838068452. b. Model No. 782105; UDI-DI 00884838098312. All units affected
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Unknown
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.