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Body 13 MR Coil 1.5T
Siemens Shenzhen Magnetic Resonance Ltd. · Model 10838410 · UDI-DI 04056869039077
10
510(k) clearances
4,751
Adverse events (37 deaths)
711
Recalls
145
Facilities
Description
MRI Coil
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A 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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Get your free API keyRead the docsData 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.
