FDAFDA · Food and drugs·Recall number Z-0949-2024
Achieva XR. Model (REF) Numbers 781153, 781253.
Published February 7, 2024 · Recall initiated: January 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- a. Model No. 781153; UDI-DI N/A. b. Model No. 781253; UDI-DI N/A. All units affected
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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