Philips ST SENSE Breast Coil Recalled for Potential Patient Safety Risk
Philips is recalling 5,231 ST SENSE Breast Coils nationwide due to a potential safety issue that could harm patients during MRI scanning. Affected units are identified by specific serial numbers.
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 involving a potential patient harm hazard. No illnesses or injuries have been reported. Per FDA rubric, risk-of-harm products where injury has not yet been reported receive a High (3) severity rating.
Plain-English summary
Philips North America LLC is recalling 5,231 units of the ST SENSE Breast Coil used in MRI breast imaging. The recalled units are identified by specific serial numbers.
The recall is being issued due to a potential safety issue where a patient may be harmed while preparing for or during a scan. This is a Class II FDA recall.
The recalled coils have been distributed nationwide. Healthcare facilities that use this equipment should check their serial numbers against the list provided.
Patients who have questions about their care should contact their healthcare provider. Healthcare facilities should consult the manufacturer regarding appropriate measures for affected equipment.
The recalled product
- Product
- ST 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: 453530054571
- UDI-DI: 00884838066625
- Serial No. 36577
- 36597
- 36664
- 36706
- 36540
- 36604
- 36590
- 36670
- 36671
- 36704
- 36710
- 36712
- 36524
- 36555
- 36519
- 36521
- 36570
- 36573
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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