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Shoulder coil kit c035

Siemens Shenzhen Magnetic Resonance Ltd. · Model 10019365 · UDI-DI 04056869049694

LNH
3
510(k) clearances
4,751
Adverse events (37 deaths)
711
Recalls
145
Facilities

Description

Contains Medical Device Mat. 8635620 (GTIN:04056869038865)

Recalls

DateFirmReason
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the

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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.