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Acessa ProVu PFG Table Clamp

ACESSA HEALTH INC. · Model MS-05-0257 · UDI-DI 00854763006249

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10
510(k) clearances
4,015
Adverse events (23 deaths)
147
Recalls
396
Facilities

Description

Field generator clamp assembly that connects the Planar Field generator to the hospital bed

Recalls

DateFirmReason
2025-11-17Sheathing Technologies IncVaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.

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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.