SENSE Breast Coil 3.0T recalled due to potential patient safety hazard
Philips is recalling approximately 5,231 SENSE Breast Coil 3.0T units due to a potential safety hazard that could harm patients during MRI scanning procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is a Class II FDA recall of a medical device with a potential safety hazard that could harm patients during clinical use. No injuries or illnesses have been reported, and the specific hazard mechanism is not detailed in the source material, making this a risk-of-harm product without confirmed harm.
Plain-English summary
Philips North America Llc is recalling the SENSE Breast Coil 3.0T, a component used in breast MRI scanning systems. Approximately 5,231 units were distributed nationwide.
The FDA has classified this as a Class II recall due to a potential safety issue that could harm patients while preparing for or during MRI scans. The specific nature of the potential hazard is not detailed in the publicly available recall notice.
Affected units can be identified by REF number 453530089302, UDI-DI 00884838065413, and serial numbers including 16, 7, 22, and 52. Healthcare facilities using this equipment are advised to review the recall details and contact Philips for further information regarding this product.
The recalled product
- Product
- SENSE Breast Coil 3.0T 7ch
- Manufacturer
- Philips North America Llc
- Hazard
- 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 (6)
- REF: 453530089302
- UDI-DI: 00884838065413
- Serial No. 16
- 7
- 22
- 52.
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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