ST SENSE Breast Dx Coil recall
ST SENSE Breast Dx Coil
Why was ST SENSE Breast Dx Coil recalled?
Potential safety issue where a patient may be harmed while preparing for or during a scan.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF: 453530264791; UDI-DI: 00884838066823; Serial No. 55, 3, 9, 36, 40, 56, 35, 39, 80, 46, 29, 7, 28, 55, 47, 54.
- Product
- ST SENSE Breast Dx Coil
- Recalling firm
- Philips North America Llc
- Quantity
- 5,231 units
- Distribution
- US Nationwide distribution.
- Recall date
- December 4, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)