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1.5T Shoulder Coil Set

Siemens Shenzhen Magnetic Resonance Ltd. · Model 10500093 · UDI-DI 04056869015057

LNHMOSLNI
10
510(k) clearances
4,751
Adverse events (37 deaths)
699
Recalls
145
Facilities

Description

Contains Medical Devices Mat. 10500081 (GTIN:04056869014999) and Mat.10500082 (GTIN:04056869015002)

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.