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Flex Small 4 MR coil 1.5T

Siemens Healthcare GmbH · Model 10185553 · UDI-DI 04056869014791

LNHMOSLNI
4
510(k) clearances
4,713
Adverse events (37 deaths)
699
Recalls
144
Facilities

Description

MRI Coil

Recalls

DateFirmReason
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14Philips North AmericaThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.