Philips Mammotrak Interventional Coil MRI Device Recalled for Patient Safety
Philips recalls 5,231 Mammotrak Interventional Coil 3.0T MRI devices nationwide due to a potential safety issue that could harm patients during scan preparation or imaging.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall describing a potential patient safety issue in MRI procedures. The source text does not report confirmed injuries or illnesses, only theoretical risk. Per the rubric, risk-of-harm products without confirmed injury are scored as High.
Plain-English summary
Philips North America LLC is recalling approximately 5,231 units of the Mammotrak Interventional Coil 3.0T, a medical device used in MRI imaging. This device has been distributed nationwide in the United States.
The FDA is issuing this recall due to a potential safety issue where patients may be harmed while preparing for or during an MRI scan with this device. The specific nature of the safety hazard has not been detailed in the recall notice.
Healthcare providers and imaging centers using this device should discontinue use and contact Philips for instructions regarding the recalled units. Patients who have had procedures using this device and have concerns should consult their healthcare provider.
The recalled product
- Product
- Mammotrak Interventional Coil 3.0T
- Manufacturer
- Philips North America Llc
- Affected units
- 5,231
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- REF: 453530228891
- UDI-DI: 00884838065857
- Serial No. 73
- 96
- 58
- 95
- 119
- 26
- 16
- 56
- 94
- 38
- 28
- 66
- 135
- 120
- 2
- 76.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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