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saturn® 450/300rs

h/p/cosmos sports & medical gmbh · Model cos30013-01va01 · UDI-DI 04050588001995

IOL
10
510(k) clearances
153
Adverse events (1 deaths)
19
Recalls
25
Facilities

Recalls

DateFirmReason
2023-05-12Full Vision IncTreadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
2023-05-12Full Vision IncTreadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
2023-05-12Full Vision IncTreadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
2023-05-12Full Vision IncTreadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
2023-05-12Full Vision IncTreadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
2023-05-12Full Vision IncTreadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
2023-05-12Full Vision IncTreadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
2022-08-31Full Vision IncThis has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnet
2022-08-31Full Vision IncThis has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnet
2022-08-31Full Vision IncThis has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnet

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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.