Philips Mammotrak Diagnostic Coil 3.0T Recall Due to Patient Safety Risk
Philips is recalling 5,231 Mammotrak Diagnostic Coil 3.0T units due to a potential safety issue that could harm patients during MRI scan preparation or scanning.
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 FDA Class II device recall identifies a potential safety issue capable of harming patients with no reported injuries to date. Per the FDA severity rubric, risk-of-harm products where injury has not yet been reported qualify as High severity.
Plain-English summary
Philips North America Llc is recalling 5,231 units of the Mammotrak Diagnostic Coil 3.0T, an MRI diagnostic device. The devices were distributed nationwide in the United States.
A potential safety issue has been identified that could result in patient harm during the preparation for or during an MRI scan. Affected devices are identified by the following serial numbers: 91, 130, 80, 53, 90, 11, 58, 25, 51, 4, 67, 34.
Patients who have received MRI scans using this device and healthcare facilities operating this equipment should be informed of this recall. If you have had an MRI scan with this coil or are scheduled for one, contact your healthcare provider about whether this recall affects your care.
The recalled product
- Product
- Mammotrak Diagnostic Coil 3.0T
- 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 (14)
- REF: 453530228911
- UDI-DI: 00884838066786
- Serial No. 91
- 130
- 80
- 53
- 90
- 11
- 58
- 25
- 51
- 4
- 67
- 34.
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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