Mammotrak Diagnostic Coil 3.0T
Class I - DangerousWhat Should You Do?
- Check if you have this product: REF: 453530228911; UDI-DI: 00884838066786; Serial No. 91, 130, 80, 53, 90, 11, 58, 25, 51, 4, 67, 34.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips North America Llc
- Reason for Recall:
- Potential safety issue where a patient may be harmed while preparing for or during a scan.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Mammotrak Diagnostic Coil 3.0T
Product Codes/Lot Numbers:
REF: 453530228911; UDI-DI: 00884838066786; Serial No. 91, 130, 80, 53, 90, 11, 58, 25, 51, 4, 67, 34.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0543-2025
Related Recalls
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Philips North America
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
Philips North America
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.