The Recall Desk
HighFDA (Devices)·Z-3202-2024·Announced 2024-10-02

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.

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: 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
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.

See all 13 products in this recall →