Philips dS Breast MRI System Recalled for Patient Safety Hazard
Philips dS Breast 16ch 3.0T MRI systems are being recalled due to a potential safety issue that could harm patients during medical scans. The FDA-mandated Class II recall affects 5,231 units distributed nationwide.
What this means for you
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 medical device recall for a potential patient safety hazard during medical imaging procedures where no illnesses or injuries have been reported, meeting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The Philips dS Breast 16ch 3.0T is a magnetic resonance imaging (MRI) system used for breast imaging procedures. The U.S. Food and Drug Administration (FDA) issued a Class II recall affecting approximately 5,231 units distributed nationwide in the United States.
The recall addresses a potential safety issue where a patient may be harmed while preparing for or during a scan. The FDA recall notice does not specify the precise nature of the hazard or available corrective actions.
Individuals who are scheduled for breast MRI procedures using affected equipment should contact their healthcare provider or imaging facility for information about this recall. Hospitals and imaging centers operating the Philips dS Breast 16ch 3.0T should contact the manufacturer, Philips North America LLC, for guidance.
The recalled product
- Product
- dS Breast 16ch 3.0T
- Manufacturer
- Philips North America Llc
- Hazard
- patient-safety-hazard
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: 453530280731
- 459801290741
- 459801290744
- 459801729891
- 459801729892
- UDI: 00884838065840
- 00884838086197
- 00884838098381
- 00884838118041
- Serial No. 538
- 170
- 437
- 14
- 124
- 189
- 291
- 194
- 516
- 412
- 154
Distribution
Distributed nationwide across the United States.
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