Mammotrak Interventional Coil 1.5T recalled for patient safety risk
Philips is recalling 5,231 units of the Mammotrak Interventional Coil 1.5T nationwide due to a potential safety issue that may harm patients during MRI preparation or scanning.
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: This FDA Class II recall describes a potential safety issue with no reported injuries or deaths. Per the rubric, when no illnesses or injuries are reported and the hazard is theoretical, the maximum score is High (3).
Plain-English summary
Philips North America Llc is recalling 5,231 units of the Mammotrak Interventional Coil 1.5T, distributed nationwide throughout the United States. The device is used in diagnostic MRI procedures.
The FDA classified this as a Class II recall due to a potential safety issue where patients may be harmed while preparing for or during MRI scanning procedures. The specific mechanism or nature of the potential hazard is not detailed in the recall notice. Affected devices can be identified using reference code REF: 453530228882, UDI-DI: 00884838066779, and serial numbers: 69, 82, 143, 64, 77, 87, 76, 81, 134, 124, 141, 103, 135, 138, 73, 72, and 131.
Healthcare facilities and providers using this device should consult the FDA and Philips North America for additional information, risk assessment, and guidance on appropriate actions regarding continued use or device replacement.
The recalled product
- Product
- Mammotrak Interventional Coil 1.5T
- Manufacturer
- Philips North America Llc
- Hazard
- patient-harm-risk
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 (19)
- REF: 453530228882
- UDI-DI: 00884838066779
- Serial No. 69
- 82
- 143
- 64
- 77
- 87
- 76
- 81
- 134
- 124
- 141
- 103
- 135
- 138
- 73
- 72
- 131.
Distribution
Distributed nationwide across the United States.
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