Philips MRI Scanner Quadrature Coil Seal Adhesive May Fail and Create Sharp Edges
Philips Intera 1.5T Achieva Nova MRI machines (Model 781172) may develop seal adhesive failure in the Quadrature Body Coil, creating sharp edges that could injure patients during scanning.
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 a medical device with a risk-of-harm scenario—seal adhesive failure could create sharp edges resulting in patient contact and potential injury (abrasions, lacerations, tissue damage). No illnesses or injuries have been reported in the source text; the risk is theoretical in terms of documented actual harm, placing this at Score 3 under the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
The Intera 1.5T Achieva Nova MRI scanner manufactured by Philips North America (Model 781172) is subject to a recall due to potential failure of the Quadrature Body Coil (QBC) seal adhesive. If the seal becomes loose during the scanning process, sharp edges may form and come into contact with patients.
The potential injuries from this hazard include skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury. The recall affects 12 units in the United States and 45 units outside the United States.
The recalled product
- Product
- Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
- Manufacturer
- Philips North America
- Hazard
- sharp-edges
- laceration
- abrasion
- tissue-injury
- entanglement
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 (2)
- Model No. 781172
- .UDI-DI N/A All units affected
Distribution
Distributed nationwide across the United States.
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