Philips Ingenia 3.0T CX MRI: Loose Coil Seal May Cause Sharp Edges
Philips is recalling Ingenia 3.0T CX MRI machines due to potential failure of the Quadrature Body Coil seal adhesive. Loose seals may create sharp edges that risk skin injury or hair entanglement during 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 recall poses risk of patient harm through sharp edges and seal failure. The source text does not report any actual illnesses, injuries, or hospitalizations; the hazard is demonstrated but not yet realized. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Philips North America is recalling the Ingenia 3.0T CX Model MRI machines (Model Numbers 781271 and 782105). This recall affects 1 unit distributed in the United States and 347 units distributed outside the United States.
The Quadrature Body Coil (QBC) seal adhesive used in these devices may fail during operation. When the seal becomes loose, it can create sharp edges that come into contact with patients during scanning.
Patients may experience skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury if the loose coil seal contacts them during the scanning process.
If you operate or maintain one of these devices, contact Philips North America for repair or replacement instructions. Do not use the device until the seal failure issue has been resolved.
The recalled product
- Product
- Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
- Manufacturer
- Philips North America
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 (3)
- a. Model No. 781271
- UDI-DI 00884838068452. b. Model No. 782105
- UDI-DI 00884838098312. All units affected
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Philips North America 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 12 products in this recall →Related recalls
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