International safety notice

SOMNObalance, SOMNOsoft 2, prisma SOFT and prisma SMART

Ireland / HPRA · IRL · Dec 4, 2018

Key facts

Title SOMNObalance, SOMNOsoft 2, prisma SOFT and prisma SMART
Regulator Ireland / HPRA
Country IRL
Brand SOMNObalance, SOMNOsoft 2, prisma SOFT and prisma SMART
Manufacturer Löwenstein Medical Technology GmbH + Co. KG
Models WM27410, DE61200700000640305900, DE25ZZZ00000353957, 54702-0, WM29707, 54702-461, WM31631HL-4110, WM31631-1110, 118051598, WM31601HL-4110, 24480, WM31601-1110 and 15 more
Event type Safety Notice
Date Dec 4, 2018
Regulator page hpra.ie

At a glance

  • No Recall
  • Yes Field safety notice

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

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