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Armboard short

Reison Medical AB · Model 10-380-UK-K · UDI-DI 07350111830366

LGX
10
510(k) clearances
80
Adverse events
15
Recalls
48
Facilities

Recalls

DateFirmReason
2023-12-05Oakworks IncBackrest platform stress fracture - the table is not operational in an inclined position
2023-12-05Oakworks IncBackrest platform stress fracture - the table is not operational in an inclined position
2023-12-05Oakworks IncBackrest platform stress fracture - the table is not operational in an inclined position
2023-12-05Oakworks IncBackrest platform stress fracture - the table is not operational in an inclined position
2021-06-29Oakworks IncWeld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-functional
2019-05-06Maquet Cardiovascular Us Sales, LlcUser may suffer an electric shock when coming in contact with the exposed electronic components
2018-03-29Brewer Company, LLCOne lot, the wire harness was over-crimped on some of the connectors that go to the two vertical side switches on the exam table.
2016-09-02Heritage Medical Products, Inc.Potential for bed to drop suddenly at the head while a patient is laying on it.
2014-07-10Medical Positioning IncExcessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a c
2014-07-10Medical Positioning IncExcessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a c

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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.