Philips MR 7700 MRI Scanner Recall for Loose Screws
Philips is recalling 7 MR 7700 MRI scanners because loose screws may block the tabletop, potentially delaying diagnosis or 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: The recall involves a risk-of-harm product (MRI scanner) where the defect could lead to delayed diagnosis or patient anxiety, but no injuries or illnesses have been reported.
Plain-English summary
Philips North America LLC is recalling seven units of the MR 7700 diagnostic MRI scanner. The recall is due to a defect where screws in the Integrated Radio Frequency (IRF) Carrier assembly may come loose and protrude beyond the surface. These protruding screws can interfere with other moving parts, potentially blocking the horizontal tabletop.
The malfunction may lead to a delay in diagnosis or cause patient anxiety if a patient is left on the tabletop inside the bore for a longer duration than anticipated. The affected units were distributed worldwide, including in the United States and numerous other countries.
Healthcare facilities should contact Philips North America LLC for instructions on how to resolve the issue. The recall number is Z-3202-2024.
The recalled product
- Product
- MR 7700 -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: 782120
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Scanner
- Affected units
- 7
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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