CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report
Mammotrak Diagnostic Coil 1.5T recalled by Philips North America
Philips North America is recalling Mammotrak Diagnostic Coil 1.5T, distributed nationwide in the US. The recall was initiated on 4 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0541-2025
- FDA event ID
- 95645
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Nov 2024
- FDA classified
- 25 Nov 2024
- Reported
- 4 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Nov 2024 | Recall initiated by company | |
| 25 Nov 2024 | Classified by FDA | +21 days |
| 4 Dec 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Product as listed by the FDA
Mammotrak Diagnostic Coil 1.5T
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Which lots 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.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 95645This product is part of a recall event; the main page for the event is dS Breast 16ch 1.5T recalled by Philips North America.
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