Recall Z-0950-2024 ยท LNI System, Nuclear Magnetic Resonance Spectroscopic
Philips North America
Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
| Date | Feb 1, 2024 (initiated Jan 3, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On January 4, 2024, the firm began notification of affected customers via URGENT Medical Device Correction letters. Customers were provided with precautions to take when using the device, including inspection of the QBC seal for separation. If the QBC seal is found to be loose, or becomes loose during a patient scan, customers should immediately stop use and contact their local Philips service representative. Customers should also ensure that all users of the device are aware of the issue and retain the letter with affected systems until a solution is installed. Philips will contact customer |
| Quantity | 0 US; 146 OUS |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., Apr 10, 2020 |