Z-0947-2024 Class II Ongoing
FDA device recall Z-0947-2024 was initiated by Philips North America on Jan 3, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 23 US; 51 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 7, 2024
- Initiation Date
- Jan 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 US; 51 OUS
Product Description
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
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 Pattern
Worldwide - US Nationwide distribution.
Code Information
Model No. 781346 UDI-DI N/A All units affected
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0947-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026