NA
GE HEALTHCARE(TIANJIN) COMPANY LIMITED · Model 1.5T EXPRESS COIL - 16E HEAD NECK ARRAY · UDI-DI 00840682118958
1
510(k) clearances
4,713
Adverse events (37 deaths)
699
Recalls
144
Facilities
Description
1.5T 16 CHANNEL,HEAD NECK ARRAY
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-14 | Philips North America | The 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 |
| 2026-04-14 | Philips North America | The 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 |
| 2026-04-14 | Philips North America | The 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 |
| 2026-04-14 | Philips North America | The 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 |
| 2026-04-14 | Philips North America | The 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 |
| 2026-04-14 | Philips North America | The 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 |
| 2026-04-14 | Philips North America | The 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 |
| 2026-04-14 | Philips North America | The 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 |
| 2026-04-14 | Philips North America | The 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 |
| 2026-04-14 | Philips North America | The 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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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.