Philips Achieva TX Interventional Coil 3.0T Recalled for Patient Safety Risk
Philips recalls the Achieva TX Interventional Coil 3.0T (5,231 units) for a potential safety issue that may harm patients during MRI scan preparation or procedures.
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: Classified as FDA Class II with no reported patient injuries or illnesses. The source describes the hazard as potential rather than confirmed. Per the severity rubric, a Class II medical device recall describing a risk-of-harm scenario where injury has not yet been reported qualifies as High (Score 3).
Plain-English summary
Philips North America LLC is recalling the Achieva TX Interventional Coil 3.0T, a medical device used in MRI imaging procedures at 3.0 Tesla field strength.
The recall addresses a potential safety issue where patients may be harmed while preparing for or during an MRI scan. The specific failure mode is not detailed in the available recall information.
Approximately 5,231 units were distributed nationwide throughout the United States. The recall was issued by the FDA as a Class II recall.
The recalled product
- Product
- Achieva TX Interventional Coil 3.0T
- Manufacturer
- Philips North America Llc
- Hazard
- patient-harm-risk
- device-malfunction
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: 453530264711
- UDI: 00884838066175
- Serial No. 171
- 318
- 274
- 333
- 116
- 120
- 169
- 177
- 449
- 430
- 280
- 460
- 301
- 287
- 539
- 545
- 182
- 502
Distribution
Distributed nationwide across the United States.
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