Philips SENSE Breast Coil Recall for Potential Patient Safety Hazard
Philips is recalling 5,231 SENSE Breast Coils due to a potential patient safety hazard during scan preparation and performance. The FDA has not disclosed specific details about the nature of the risk.
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 medical device recall with potential patient harm risk during medical procedures. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3.
Plain-English summary
Philips North America LLC is recalling 5,231 SENSE Breast Coils distributed nationwide in the United States. 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 a scan.
The recalled coils are identified by serial numbers ranging from 36537 to 37283. Affected healthcare facilities should identify any units with the listed serial numbers and discontinue their use. The specific nature of the safety hazard has not been detailed in the FDA recall notice.
Healthcare providers and medical facilities with matching serial numbers should immediately stop using the affected units and contact Philips North America LLC or the FDA for further guidance regarding replacement or repair options.
The recalled product
- Product
- SENSE Breast Coil
- 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 (20)
- REF: 453530083951
- UDI-DI: 00884838066588
- Serial No. 36987
- 36587
- 36690
- 36898
- 37009
- 36637
- 37129
- 37140
- 36957
- 36549
- 36548
- 36547
- 36893
- 36678
- 36736
- 36743
- 36744
- 36763
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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