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8.2MHZ PENCIL PROBE 841-A

PARKS MEDICAL ELECTRONICS, INC. · Model 832-1820-21 · UDI-DI 00816787020007

JOP Prescription
10
510(k) clearances
24
Adverse events (2 deaths)
1
Recalls
15
Facilities

Recalls

DateFirmReason
2014-06-26Biosound Esaote, Inc.Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.