Philips dS Breast 7ch 3.0T MRI Coil Recalled for Patient Safety Hazard
Philips is recalling 5,231 dS Breast 7ch 3.0T breast MRI coils distributed nationwide due to a potential safety issue that may harm patients during scan preparation or scanning. The FDA classified this as Class II.
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: FDA Class II recall with a potential patient safety hazard during device operation. No specific injuries, hospitalizations, or deaths were reported in the source. This is a risk-of-harm situation without documented harm, which corresponds to Score 3 (High) per the rubric.
Plain-English summary
Philips North America LLC is recalling approximately 5,231 dS Breast 7ch 3.0T breast coils, which are used as receivers in 3.0-tesla MRI systems for breast imaging. The FDA classified this recall as Class II.
A potential safety issue has been identified where a patient may be harmed during scan preparation or while undergoing a scan with these coils. The specific nature of the safety hazard was not detailed in the FDA notice.
The affected devices were distributed nationwide throughout the United States to healthcare facilities. The devices are identified by specific reference numbers (REF: 453530280891, 453530280892, 459801290711, 459801290712, 459801729911, 459801729912, 459801729913) and UDI-DI codes (00884838066168, 00884838086173, 00884838098404, 00884838107953, 00884838118294).
Healthcare facilities using these coils should contact Philips for replacement options or remedial instructions.
The recalled product
- Product
- dS Breast 7ch 3.0T
- 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: 453530280891
- 453530280892
- 459801290711
- 459801290712
- 459801729911
- 459801729912
- 459801729913
- UDI-DI: 00884838066168
- 00884838086173
- 00884838098404
- 00884838107953
- 00884838118294
- Serial No. 1050
- 632
- 709
- 981
- 944
- 1060
- 175
- 703
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.
See all 13 products in this recall →Related recalls
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See all →- HighPhilips dS Breast MRI System Recalled for Patient Safety Hazard
FDA (Devices) · 2024-12-04
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