FDAClass IIDecember 4, 2024

Mammotrak Diagnostic Coil 1.5T recall

Mammotrak Diagnostic Coil 1.5T

Why was Mammotrak Diagnostic Coil 1.5T 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: 453530228872; UDI-DI: 00884838066762; Serial No. 79, 124, 71, 179, 124, 182, 45, 43, 178, 171, 181, 53, 40, 52, 69, 187, 95.

Product
Mammotrak Diagnostic Coil 1.5T
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)
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