Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
This recall is currently active, issued February 1, 2024. It was issued by Philips North America.
- Company
- Philips North America
- Recall Initiated
- January 3, 2024
- Posted
- February 1, 2024
- Recall Number
- Z-0945-2024
- Quantity
- 119 US; 1,807 OUS
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
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.
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.
Root Cause
Process control
Action Taken
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 customers to schedule a time for a Field Service Engineer (FSE) to visit your site and replace your system's QBC Seal. Philips plans to start implementing corrections in Q3 2024. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377). Revision B of the URGENT Medical Device Correction letter was distributed to the additional US consignees on 24-Mar-2025. It was later identified that UMDC Rev B contained three MR systems with a 70cm bore (Ingenia 1.5T: 781341, Ingenia 3.0T: 781377, Ingenia Ambition X: 782109) which were incorrectly included, as the scope of this field action is MR systems with 60cm bore. The URGENT Medical Device Correction letter was updated to Rev C to remove these systems. Revision C of the UMDC was distributed to the additional US consignees on 09-Apr-2025.