Philips Ingenia 1.5T MRI Device Recall: Loose Screws May Block Tabletop
Philips recalls certain Ingenia 1.5T MRI devices due to loose assembly screws that may block the patient tabletop, potentially delaying diagnosis and causing patient anxiety.
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 is an FDA Class II recall with no reported illnesses, hospitalizations, or injuries. The hazard is theoretical—loose screws could interfere with the patient tabletop—but actual patient harm has not been documented, making this a High (3) severity per the rubric.
Plain-English summary
Philips North America LLC is recalling 48 Ingenia 1.5T magnetic resonance imaging (MRI) devices distributed worldwide. The devices are used for diagnostic imaging of the head, body, or extremities.
The Integrated Radio Frequency (IRF) Carrier assembly screws in these devices may become loose and protrude beyond the surface. This could cause the screws to interfere with other moving parts, potentially blocking the horizontal patient tabletop.
If the patient tabletop becomes blocked, patients may remain positioned inside the MRI bore longer than necessary, potentially causing diagnostic delays and patient anxiety.
Healthcare facilities operating affected Ingenia 1.5T MRI devices should contact Philips for information regarding inspection and corrective action.
The recalled product
- Product
- Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140
- Manufacturer
- Philips North America Llc
- Affected units
- 48
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 UDI-DI: 782115 (01)00884838099043(21)
- 782101 (01)00884838098275(21)
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.
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