FDA Enforcement
Class II
Ongoing
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
Recall: Z-0947-2024
·
Reported February 7, 2024
Enforcement
- Recall Number
- Z-0947-2024
- Event ID
- 93787
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 7, 2024
- Initiation Date
- January 3, 2024
- Classification Date
- February 1, 2024
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2296, United States
Description
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
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 Info
Model No. 781346 UDI-DI N/A All units affected
Distribution
Worldwide - US Nationwide distribution.
Quantity
23 US; 51 OUS