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GE HEALTHCARE(TIANJIN) COMPANY LIMITED · Model EXPRESS COIL - HEAD NECK ARRAY · UDI-DI 00840682118934

LNILNH
1
510(k) clearances
15
Adverse events
17
Recalls
49
Facilities

Description

HEAD NECK ARRAY, 1.5T EXPRESS COIL

Recalls

DateFirmReason
2024-01-03Philips North AmericaThe Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the r
2024-01-03Philips North AmericaThe Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the r
2024-01-03Philips North AmericaThe Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the r
2024-01-03Philips North AmericaThe Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the r
2024-01-03Philips North AmericaThe Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the r
2024-01-03Philips North AmericaThe Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the r
2024-01-03Philips North AmericaThe Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the r
2024-01-03Philips North AmericaThe Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the r
2024-01-03Philips North AmericaThe Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the r
2024-01-03Philips North AmericaThe Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the r

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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.