Mammotrak Diagnostic Coil 1.5T Recalled Due to Patient Safety Concern
Philips is recalling 5,231 Mammotrak Diagnostic Coil 1.5T units nationwide because of a potential patient safety issue during MRI scans. The FDA has classified this as a Class II recall.
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 an FDA Class II recall involving a potential patient safety risk during a medical procedure. No illnesses or injuries have been reported in the source. Per the severity rubric, a risk-of-harm product where injury has not yet been reported warrants a score of 3 (High).
Plain-English summary
Philips North America LLC is recalling 5,231 Mammotrak Diagnostic Coil 1.5T units used in MRI equipment. These units have been distributed nationwide in the United States.
The FDA has classified this as a Class II recall due to a potential safety issue where patients may be harmed during MRI scan preparation or while the scan is being performed.
Patients who have undergone or are scheduled to undergo MRI scans with this equipment should contact their healthcare provider or imaging facility to determine if they were affected by this recall. Healthcare facilities should contact Philips regarding remediation and any necessary corrective actions.
The recalled product
- Product
- Mammotrak Diagnostic Coil 1.5T
- 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: 453530228872
- UDI-DI: 00884838066762
- Serial No. 79
- 124
- 71
- 179
- 182
- 45
- 43
- 178
- 171
- 181
- 53
- 40
- 52
- 69
- 187
- 95.
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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